Model Number V173 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/06/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Information indicates this device is currently in the possession of a boston scientific representative.This investigation will be updated should further information be provided.
|
|
Event Description
|
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device was nearing elective replacement indicator (eri) status and reverted to safety mode with limited critical therapy still available.The patient was noted to not be device therapy dependent.The device was explanted and replaced.There were no additional adverse patient effects.
|
|
Manufacturer Narrative
|
Information indicates this device is currently in the possession of a boston scientific representative.This investigation will be updated should further information be provided.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 due to system resets.It was confirmed that brady therapy remained available.The system resets occurred during a telemetry session and 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 related to telemetry attempts 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.
|
|
Event Description
|
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device was nearing elective replacement indicator (eri) status and reverted to safety mode with limited critical therapy still available.The patient was noted to not be device therapy dependent.The device was explanted and replaced.There were no additional adverse patient effects.
|
|
Search Alerts/Recalls
|