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

Model Number	V173
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) entered safety mode.The crt-p was explanted, and another device was successfully placed.This device was received for analysis.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) entered safety mode.The crt-p was explanted, and another device was successfully placed.This device was received for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This cardiac resynchronization therapy pacemaker (crt-p) was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device could not be interrogated and was exhibiting no pacing pulses.The device case was removed to facilitate inspection and testing of the internal components.The battery was removed and replaced with an external power source to test the performance of the hybrid circuit.Testing of the hybrid circuit confirmed a normal current drain.The battery was forwarded for detailed analysis and while the battery was confirmed to be depleted, the root cause could not be conclusively determined.
Additional Manufacturer Narrative
This report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with capa-8580, which focused on identifying and remediating incomplete coding of events.Added patient code e2131.This cardiac resynchronization therapy pacemaker (crt-p) was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device could not be interrogated and was exhibiting no pacing pulses.The device case was removed to facilitate inspection and testing of the internal components.The battery was removed and replaced with an external power source to test the performance of the hybrid circuit.Testing of the hybrid circuit confirmed a normal current drain.The battery was forwarded for detailed analysis and while the battery was confirmed to be depleted, the root cause could not be conclusively determined.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) entered safety mode.It was noted the patient felt different when device entered safety mode and technical services discussed this was most likely stimulation due to the unipolar pacing.The crt-p was explanted, and another device was successfully placed.This device was received for analysis.No additional adverse patient effects were reported.

• Brand Name: INVIVE?
• Common Device Name: 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: 21428990
• Report Number: 2124215-2025-10489
• Device Sequence Number: 14584761
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: (01)00802526536632(17)160225(21)105837
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2026

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: 02/25/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 105837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 05/30/2025; 04/14/2026
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 06/13/2025; 04/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male