MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, PACEMAKER, WITH CRT-P

Model Number V173

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

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

This 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 the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room (er) due to feeling muscle stimulation in their chest. Upon interrogation, the device was found to be operating in safety mode. The device was subsequently explanted and replaced. No additional adverse patient effects were reported.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, PACEMAKER, WITH CRT-P
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12113385
• MDR Text Key: 260028324
• Report Number: 2124215-2021-13653
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/05/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 102962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2013
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/03/2021 Patient Sequence Number: 1