Latest Device Alerts
Abbott | St Jude Medical
- *NEW Abbott: AveirTM VR Leadless PAcemakers Model LSP112V (April 2024)
- Abbott: GALLANTTM, NEUTRINOTM NXT, and ENTRANTTM 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.
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.
If "Hold to Test" pressed and released prior to first voltage decrement, the programmer may continue the Decrement Test instead of terminating the test.
Incomplete epoxy mixing causing moisture into header, causing loss of telemetry, reduced longevity, loss of pacing and shorter ERI to EOS time.
Software upgrade info.
Biotronik
Potential for lithium plating in battery that may cause a battery drain at a higher rate than under typical use.
Boston Scientific | Cameron Health
Software issue which can lead to loss of device sensing.
May initiate Safety Mode related to telemetry attempts. Basic therapy is still provided in Safety Mode, replacement is required.
- Boston Scientific EmblemTM and Emblem MRITM (S-ICDs) update Jun 2021 (link to previous Aug 2019)
May have compromised performance of an electrical component causing accelerated battery depletion.
- Boston Scientific ACCOLADETM, PROPONENTTM, ESSENTIOTM pacemakers and VISIONISTTM and VALITUDETM CRTPs (October 2018)
- Boston Scientific ACCOLADETM, PROPONENTTM, ESSENTIOTM & ALTRUA 2TM pacemakers and VISIONISTTM and VALITUDETM CRTPs (June 2021) (expansion of October 2018)
Hydrogen-induced accelerated battery depletion. Expansion of issue reported in Oct 2018. No follow up change required.
- Boston Scientific EMBLEMTM 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.
Electrode body fractures at a location just distal to the proximal sense ring.
Shortened replacement interval after ERI
Intermittent over sensing of Minute Ventilation sensor causing periods of pacing inhibition.
- Boston Scientific VALITUDETM CRT-P, RESONATETM CRT-D, MOMENTUMTM CRT-D, AUTOGENTM CRT-D, VISIONISTTM CRT-P, DYNAGENTM CRT-D (24 Dec 2017)
- Boston Scientific EMBLEMTM S-ICDs Models A209 and A219 and SQ-RXTM S-ICDs Model 1010 (July 2017)
- Boston Scientific Model 3200 S-ICD Programmer (20 Jan 2017)
Medtronic
A subset of devices with a manufacturing defect are susceptible to increased noise due to moisture affecting the electrode performance.
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.
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.
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.
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.
After partial electrical reset, usually after DCCV or electrocautery, Brady & Pause events appear to be "ON", but are no longer able to detect/report.
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.
VF zone ATP may not be automatically enabled and may require manual programming.
- Medtronic 2090 Carelink Programmer, 29901 Encore Programmer, Carelink Network Software 2491 (Feb 2019)
Update required to display correct longevity estimate for Micra TPS.
If error occurs, device will withhold pacing until a VS detected.
Vulnerable to being hacked when connected to internet for software upgrades.
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.
If patient has more than one CIED, they may not be able to send data or unintentionally from the other.
Microport | LivaNova | Sorin
- LivaNova: Subset of PlatiniumTM ICDs and CRTDs (July 2018)
- LivaNova (Formerly Sorin Group) Platinium ICDs and CRTDs (Sept 2017)
Hardware compoent which can cause battery overconsumption at implant and MRI