MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; IMPLANTABLE PACEMAKER

Model Number V173

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that the cardiac resynchronization therapy pacemaker (crt-p) showed nine months remaining and then two months later showed it was in safety mode.Boston scientific technical services (ts) discussed pacing will remain, but with no left ventricular (lv) offset and both right ventricular (rv) lead and lv are unipolar configuration.The crt-p was explanted and replaced the following day.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory review of the the cardiac resynchronization therapy pacemaker's (crt-p's) memory found it had never triggered the replacement indicator while implanted.Further review noted that there was a total of nine power on resets that occurred within a three month time frame.The final reset was due to three power on resets which put the device into safety mode.The crt-p passed longevity calculations.The device was put back into primary operation to complete further testing, however it was unable to complete as the device reverted back to safety mode while the test was running due to power on resets.The device passed a series of automated diagnostic testing that verifies the performance of pacing, sensing, and recording functions of the device commensurate with battery voltage.The device case was opened and a battery voltage of 2.792v was noted.The battery was removed and the current drain was within tolerance of the circuit.Further detailed analysis determined the cause of the crt-p going into safety mode was due to a shorted battery.The battery was shorted due to a tube tear.

Event Description

This report is being filed to submit the analysis results.

• Brand Name: INVIVE
• Type of Device: IMPLANTABLE PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9550698
• MDR Text Key: 173711338
• Report Number: 2124215-2019-27125
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/05/2014
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 100394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Date Manufacturer Received: 03/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR