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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
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BOSTON SCIENTIFIC CORPORATION INVIVE; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number V183
Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Human-Device Interface Problem (2949); Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
The device is undergoing laboratory analysis.This report will be updated when analysis sis complete.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) triggered an alert in the remote monitoring system indicating the device had reverted to safety mode operation, with limited function and no programming options.The device would pace in vvi mode at 72 bpm, with an output of 5 volts.The most recent latitude data was from the previous week and showed the device was not in safety mode then, but had stored several power on reset (por) faults, which were unexpected and could indicate a hardware malfunction.With the device in safety mode, no memory download would be possible and device replacement was recommended.The patient was admitted for the replacement procedure.It was noted the patient felt unwell at these device settings.External monitoring showed a two second pause in pacing due to oversensing of myopotentials that likely resulted from the unipolar pacing and sensing configuration in safety mode operation.Therefore, the device was explanted and replaced that evening.No additional adverse patient effects were reported.The explanted device was expected to be returned for analysis.The device was received and is undergoing laboratory analysis.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) triggered an alert in the remote monitoring system indicating the device had reverted to safety mode operation, with limited function and no programming options.The device would pace in vvi mode at 72 bpm, with an output of 5 volts.The most recent latitude data was from the previous week and showed the device was not in safety mode then, but had stored several power on reset (por) faults, which were unexpected and could indicate a hardware malfunction.With the device in safety mode, no memory download would be possible and device replacement was recommended.The patient was admitted for the replacement procedure.It was noted the patient felt unwell at these device settings.External monitoring showed a two second pause in pacing due to oversensing of myopotentials that likely resulted from the unipolar pacing and sensing configuration in safety mode operation.Therefore, the device was explanted and replaced that evening.No additional adverse patient effects were reported.The explanted device was expected to be returned for analysis.The device was received and is undergoing laboratory analysis.
 
Manufacturer Narrative
The device is undergoing laboratory analysis.This report will be updated when analysis sis complete.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 and that brady therapy remained available.Review of device memory identified an error, which resulted in software resets that were performed in an attempt to correct the error.These resets then caused the device to enter safety mode.The battery was removed and detailed analysis was able to confirm the cell had a high internal impedance.The high internal impedance resulted in the software resets, reversion to safety mode operation, and the reported clinical observations.
 
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Brand Name
INVIVE
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11263704
MDR Text Key229802582
Report Number2124215-2020-29204
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/23/2014
Device Model NumberV183
Device Catalogue NumberV183
Device Lot Number100047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2020
Initial Date Manufacturer Received 10/26/2020
Initial Date FDA Received02/01/2021
Supplement Dates Manufacturer Received03/02/2021
Supplement Dates FDA Received05/05/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age89 YR
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