BOSTON SCIENTIFIC CORPORATION INTUA; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
|
Back to Search Results |
|
Model Number V273 |
Device Problems
Premature Discharge of Battery (1057); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
Bradycardia (1751)
|
Event Date 11/06/2021 |
Event Type
Injury
|
Event Description
|
It was reported that this cardiac resynchronization therapy pacemaker was found to be in safety mode.During the device replacement procedure there was pacing inhibition observed.It was noted that the non boston scientific right ventricular (rv) lead exhibited loss of capture.Subsequently, the device was explanted and replaced due to premature battery depletion and the rv lead was surgically abandoned.The new device and rv lead remain in service.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
The returned cardiac resynchronization therapy pacemaker was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
|
|
Manufacturer Narrative
|
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.The returned cardiac resynchronization therapy pacemaker was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
|
|
Event Description
|
It was reported that this cardiac resynchronization therapy pacemaker was found to be in safety mode.During the device replacement procedure there was pacing inhibition observed.It was noted that the non boston scientific right ventricular (rv) lead exhibited loss of capture.Subsequently, the device was explanted and replaced due to premature battery depletion and the rv lead was surgically abandoned.The new device and rv lead remain in service.No additional adverse patient effects were reported.The returned cardiac resynchronization therapy pacemaker was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
|
|
Search Alerts/Recalls
|
|
|