Abbott | St Jude Medical

1. *NEW Abbott: Aveir^TM VR Leadless PAcemakers Model LSP112V (April 2024)  
2. Abbott: GALLANT^TM, NEUTRINO^TM NXT, and ENTRANT^TM ICDs and CRT-Ds manufactured prior to April 2022 (August 2023)

Bluetooth circult compoent issue which can: 

1. disable Bluetooth telemetry (including remote monitoring) and,

2. result in high current consumption leading to reduced device longevity. 

1. Abbott: A subset of Assurity^TM, Endurity^TM and Zenex^TM Pacemakers (August 2022)

A laser surface preparation may not have properly prepared the device's metal housing potentially leading to abnormal device-to-header adhesion which may allow  moisture ingress into the header.

1. Abbott: Merlin^TM Patient Care System (PCS) Software used in Gallant^TM, Neutrino^TM NxT, Entrant^TM devices (March 2022)

If "Hold to Test" pressed and released prior to first voltage decrement, the programmer may continue the Decrement Test instead of terminating the test. 

1. Abbott / St Jude Medical Assurity^TM and Endurity^TM Pacemakers (15 March 2021)

Incomplete epoxy mixing causing moisture into header, causing loss of telemetry, reduced longevity, loss of pacing and shorter ERI to EOS time.

1. St Jude Information About Cybersecurity for Accent^TM, Anthem^TM, Accent MRI^TM, AccentST^TM Allure^TM and Assurity MRI^TM devices (Dec 2017)

Software upgrade info.

1. St Jude Optisure Dual Coil Defibrillation Leads (12 Nov 2015) and 24 Nov 2015 Addendum

 

Biotronik

1. Biotronik: Ilesto^TM, Inventra^TM, Iperia^TM, Itrevia^TM, Ilivia^TM, Intica^TM, Intica Neo^TM ICDs and CRT-Ds distributed since 2013 (21 March 2021)

Potential for lithium plating in battery that may cause a battery drain at a higher rate than under typical use.

 

Boston Scientific | Cameron Health

1. Boston Scientific Emblem^TM S-ICD on LATITUDE remote monitoring system (October 2023)

Software issue which can lead to loss of device sensing.

1. Boston Scientific dual chamber INGENIO^TM family pacemakers and CRTPs (Jun 2021)

May initiate Safety Mode related to telemetry attempts. Basic therapy is still provided in Safety Mode, replacement is required. 

1. Boston Scientific Emblem^TM and Emblem MRI^TM (S-ICDs) update Jun 2021 (link to previous Aug 2019)

May have compromised performance of an electrical component causing accelerated battery depletion.

1. Boston Scientific ACCOLADE^TM, PROPONENT^TM, ESSENTIO^TM pacemakers and VISIONIST^TM and VALITUDE^TM CRTPs (October 2018)
2. Boston Scientific ACCOLADE^TM, PROPONENT^TM, ESSENTIO^TM & ALTRUA 2^TM pacemakers and VISIONIST^TM and VALITUDE^TM CRTPs (June 2021) (expansion of October 2018)

Hydrogen-induced accelerated battery depletion. Expansion of issue reported in Oct 2018. No follow up change required.

1. Boston Scientific EMBLEM^TM S-ICDs Models A209 and A219 (6 Dec 2020): Implanted from May 2015 to Dec 2017

Over time a pathway may develop in header that allows moisture ingress, enabling a shorting condition to occur during delivery of HV therapy.

1. Boston Scientific EMBLEM^TM S-ICD Subcutaneous Electrode (Model 3501) current model S-ICD lead/electrode (6 Dec 2020)

Electrode body fractures at a location just distal to the proximal sense ring.

1. Cameron Health Sub-Q RX Model 1010 S-ICD (18 Jan 2019)

Shortened replacement interval after ERI

1. Boston Scientific VALITUDE^TM CRT-P, VISIONIST^TM CRT-P, ACCOLADE^TM Pacemakers, PROPONENT^TM Pacemakers (24 Dec 2017)

Intermittent over sensing of Minute Ventilation sensor causing periods of pacing inhibition.

1. Boston Scientific VALITUDE^TM CRT-P, RESONATE^TM CRT-D, MOMENTUM^TM CRT-D, AUTOGEN^TM CRT-D, VISIONIST^TM CRT-P, DYNAGEN^TM CRT-D (24 Dec 2017)
2. Boston Scientific EMBLEM^TM S-ICDs Models A209 and A219 and SQ-RX^TM S-ICDs Model 1010 (July 2017)
3. Boston Scientific Model 3200 S-ICD Programmer (20 Jan 2017)

 

Medtronic

1. Medtronic - LINQ II ^TM implantable cardiac monitor (Nov 2023)

A subset of devices with a manufacturing defect are susceptible to increased noise due to moisture affecting the electrode performance.

1. Medtronic Device: Cobalt^TM XT/Cobalt^TM/Crome^TM ICDs and CRT-Ds (May 2023)

Reduced or no-energy output during HV therapy in ICDs/CRT-Ds manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

1. Medtronic Cobalt XT^TM Cobalt^TM and Crome^TM ICDs CRT-Ds (June 2022)

Potential for shocks to be ~79% of the programmed energy as a result of a safety feature, Short Circuit Protection, designed to truncate delivered energy to protect the device when unexpected current is detected during HV therapy.

1. Medtronic Cobalt^TM and Crome^TM ICDs and CRT-Ds (May 2022)

May encounter a persistent "session-active"flag following the use of inductive telemetry, typically with CareLink Express. This will result in temporary suspension of some features until the flag is cleared.

1. Medtronic Cobalt^TM and Crome^TM ICDs and CRTDs (Oct 2021)

Rarely SmartStync interrogation sessions, or CareLink network transmissions may fail for Cobalt or Crome devices when the current session diagnostic data includes any VT/VF episode type with multiple therapy sequences and three or more data recording suspensions. SmartSync will display "Unexpected error occured", and the app. requires restarting. Within CareLink, the current transmission processing may fail, and the information will not be viewable.

1. Medtronic: Reveal LINQ^TM with TruRhythm^TM ICMs (June 2021)

After partial electrical reset, usually after DCCV or electrocautery, Brady & Pause events appear to be "ON", but are no longer able to detect/report. 

1. Medtronic: Subset of CRT-Ds and ICDs, Updates (Sep & Feb 2021) from previous (22 Nov 2019)

Sept 2021 update: TGA reclassified to an "implant hazard alert". No change from previous advice or risk: Latent shorting mechanism resulting from lithium plating between annode and cathode causing rapid battery depletion.

1. Medtronic Cobalt^TM and Crome^TM ICDs and CRT-Ds (6 Dec 2020)

VF zone ATP may not be automatically enabled and may require manual programming.

1. Medtronic 2090 Carelink Programmer, 29901 Encore Programmer, Carelink Network Software 2491 (Feb 2019)

Update required to display correct longevity estimate for Micra TPS.

1. Medtronic Adapta DR (Jan 2019)

If error occurs, device will withhold pacing until a VS detected.

1. Medtronic Carelink 2090, Carelink Encore 29901/29901A programmers (18 Jan 2019)

Vulnerable to being hacked when connected to internet for software upgrades.

1. Medtronic Entrust CR/DR/AT ICDs. Models: D154ATG; D154VRC (9 July 2018)

ICD may become EOL with no prior ERI alert. May not be able to charge HV circuits, loss of HV and ATP. Brady continue to operate as expected.

1. Medtronic MyCareLink Remote Monitors: Models 24950 and 25000 (29 Nov 2017)

If patient has more than one CIED, they may not be able to send data or unintentionally from the other.

 

Microport | LivaNova | Sorin

1. LivaNova: Subset of PlatiniumTM ICDs and CRTDs (July 2018)
2. LivaNova (Formerly Sorin Group) Platinium ICDs and CRTDs (Sept 2017)

Hardware compoent which can cause battery overconsumption at implant and MRI