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

Model Number V173

Device Problems Pacing Problem (1439); Inappropriate or Unexpected Reset (2959)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2019

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 this cardiac resynchronization therapy pacemaker (crt-p) experienced a reset and went to safety mode.The cause of the reset was unknown.In addition, pacing inhibition was also observed.Boston scientific technical services (ts) recommended device replacement.Subsequently, a revision procedure was performed and the crt-p was explanted and replaced.No additional adverse patient effects were reported.

Event Description

This supplemental report is being filed as the device evaluation was completed.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Visual examination noted no anomalies.The device could be interrogated and review of device memory noted a fault was recorded on (b)(6) 2019.The device case was removed to facilitate inspection of the internal components and further testing.The battery was removed from the device and detailed analysis of the battery identified an internal short, which was caused by a tear in the cathode insulating tube.The short resulted in the fault identified in the laboratory setting, in the swollen battery, and in the clinically-observed reversion to safety mode operation.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9088709
• MDR Text Key: 159217122
• Report Number: 2124215-2019-15010
• 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: 01/07/2020

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: 06/27/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 103830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 91 YR