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

Model Number V173

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been returned at this time.If it is returned, analysis will be performed, and this report will be updated.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) reached elective replacement indicator (eri).The device then exhibited three alert codes and was found to be operating in safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 is being used to capture the additional intervention performed.The device has not been returned at this time.If it is returned, analysis will be performed, and this report will be updated.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.External visual inspection of the device revealed signs of battery swelling.The device case was then opened to facilitate analysis of the internal components.The battery was separated from the other device electronics and the overall current draw of the circuitry was measured.The battery analysis determined that there was a short in the cell caused from the cathode tab coming in contact with the can due to a torn insulator tube.This internal short in the battery was determined to be the cause for the battery depleting faster than expected and for the observed reversion to safety mode.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) reached elective replacement indicator (eri).The device then exhibited three alert codes and was found to be operating in safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10642016
• MDR Text Key: 210193005
• Report Number: 2124215-2020-19982
• 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: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/02/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 102645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 95 YR