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Abbott  |  St Jude Medical

Bluetooth circuit component 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

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

 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.

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.

Medtronic

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 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

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