Abbott | St Jude Medical
Bluetooth circuit component issue which can:
- disable Bluetooth telemetry (including remote monitoring) and,
- 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
- Boston Scientific INGENIO™ family pacemakers (December 2023) – (link to previous June 2021)
New data and recommendations for remaining Boston Scientific INGENIO™ devices
Incorrect dates are displayed on certain pacemaker models using the Model 3120 Zoom (TM) programmer following January 10, 2024.
Software issue which can lead to loss of device sensing.
- Boston Scientific Emblem™ and Emblem MRI™ (S-ICDs) update Jun 2021 (link to previous Aug 2019)
May have compromised performance of an electrical component causing accelerated battery depletion
Hydrogen-induced accelerated battery depletion. Expansion of issue reported in Oct 2018. No follow up change required.
Expanding RC-2019-RN-01242-1 device population with increased likelihood of a low voltage capacitor causing accelerated battery depletion.
- Boston Scientific EMBLEM™ 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 VALITUDE™ CRT-P, RESONATE™ CRT-D, MOMENTUM™ CRT-D, AUTOGEN™ CRT-D, VISIONIST™ CRT-P, DYNAGEN™ CRT-D (24 Dec 2017)
- Boston Scientific EMBLEM™ 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)
- Boston Scientific AUTOGEN™ DR ICDs and CRT-Ds (14 Dec 2014)
- Boston Scientific: COGNIS™ Implantable CRT-Ds and TELIGEN™ DR & VR ICDs – Addendum (10 Oct 2014) from previous (5 Sept 2013)
Medtronic
- Medtronic Device: Cobalt™ XT/Cobalt™/Crome™ ICDs and CRT-Ds – Update to risk of reduced or low energy shocks with a subset of Medtronic defibrillators (Dec 2023) (link to previous update May 2023)
Increased potential for reduced energy or no energy delivered during high voltage therapy when programmed AX > B
A subset of devices with a manufacturing defect are susceptible to increased noise due to moisture affecting the electrode performance.
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 SmartSync 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 occurred”, 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
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
Hardware component which can cause battery overconsumption at implant and MRI