Model Number K174 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/21/2023 |
Event Type
Injury
|
Event Description
|
It was reported that this pacemaker was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
If pertinent information is provided in the future, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that this pacemaker was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
If pertinent information is provided in the future, a supplemental report will be submitted.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode, it had undergone resets and that bradycardia therapy remained available.The system resets caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
|
|
Search Alerts/Recalls
|