MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE?; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number	V173
Medical Device Problem Codes	Premature Discharge of Battery (1057); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Fever (1858); Device Overstimulation of Tissue (1991); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not available at the time of this report we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted due to it switched to safety mode.A new device was successfully implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted due to it switched to safety mode.A new device was successfully implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Unique identifier (udi) d4: updated.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted due to it switched to safety mode.A new device was successfully implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted due to it switched to safety mode.A new device was successfully implanted.No additional adverse patient effects were reported.Additional information was received indicating that due to safety mode operation, the patient experienced muscle stimulation and pain at the implant site.It was also noted that there was a concern for premature battery depletion.Upon completion of the replacement procedure, the patient was administered medication for fever and pain.No additional adverse patient effects were reported.This device has not been returned.
Additional Manufacturer Narrative
Unique identifier (udi) d4: updated.

• Brand Name: INVIVE?
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
• 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: 21836656
• Report Number: 2124215-2025-23376
• Device Sequence Number: 15444690
• Product Code: NKE
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/06/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/21/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 107527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2025
• Supplement Date Received by Manufacturer: 04/15/2025; 04/10/2025; 05/22/2026; 06/15/2026
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 04/15/2025; 04/30/2025; 05/28/2026; 07/06/2026
• Date Device Manufactured: 08/26/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male