MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; IMPLANTABLE PACEMAKER WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number V173

Device Problems Premature Discharge of Battery (1057); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

Patient Problem No Code Available (3191)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

It was reported that the remote home monitoring system issued an alert showing the cardiac resynchronization therapy pacemaker (crt-p) had reached safety core and review of the electrogram noted pacing inhibition.Boston scientific technical services (ts) discussed that the device should be explanted as soon as possible.Subsequently the crt-p was explanted for suspected premature battery depletion and successfully replaced.No additional adverse patient effects were reported.

Event Description

This report is being filed to submit the analysis results.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the clinically observed error message was reproduced.Memory review confirmed that the device underwent a reset due to memory corruption which resulted in the observed error message.Following the reset, the device reverted to a safety mode with limited programmability, in which pacing therapy was available.The device case was opened and the battery was sent for additional analysis.Detailed analysis determined there was higher then normal resistance.Patient code 3191 captures the reportable event of surgery.

• Brand Name: INVIVE
• Type of Device: IMPLANTABLE PACEMAKER WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10615810
• MDR Text Key: 209461582
• Report Number: 2124215-2020-14194
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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 Date: 04/16/2014
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 100503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 12/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR