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 Syncope/Fainting (4411)

Event Date 11/16/2021

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode unexpectedly.Also noted that when this patient moves their arms, prolonged periods of pacing inhibition occurs.Technical services (ts) discussed the limited device functionality, and recommended replacement as there is no reprogramming available in safety mode.Subsequently, the crt-p was explanted and a new device of a different model, was successfully implanted.No additional adverse patient effects were reported.Return of the device is not expected.If the product is returned, analysis will be performed and this report will be updated with pertinent information, upon completion of analysis.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode unexpectedly.Also noted that when this patient moves their arms, prolonged periods of pacing inhibition occurs.Technical services (ts) discussed the limited device functionality, and recommended replacement as there is no reprogramming available in safety mode.Subsequently, the crt-p was explanted and a new device of a different model, was successfully implanted.No additional adverse patient effects were reported.Return of the device is not expected.If the product is returned, analysis will be performed and this report will be updated with pertinent information, upon completion of analysis.

• 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
• 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: 13138783
• MDR Text Key: 283296766
• Report Number: 2124215-2021-39178
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2022

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: 01/07/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 102766
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 01/02/2022
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female