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

Model Number	V173
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Chest Pain (1776); Unspecified Heart Problem (4454)
Date of Event	04/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) felt thumping on their chest.Technical services (ts) was consulted and it was discovered this crt-p entered safety mode, with the safety modes unipolar pacing probably causing the thumping felt by the patient.This crt-p was explanted.A new device was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption (during telemetry or other higher power device operations) and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) felt thumping on their chest.Technical services (ts) was consulted and it was discovered this crt-p entered safety mode, with the safety modes unipolar pacing probably causing the thumping felt by the patient.This crt-p was explanted.A new device was implanted.No additional adverse patient effects were reported.The device has been returned and analyzed.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption (during telemetry or other higher power device operations) and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) felt thumping on their chest.Technical services (ts) was consulted and it was discovered this crt-p entered safety mode, with the safety modes unipolar pacing probably causing the thumping felt by the patient.This crt-p was explanted.A new device was implanted.No additional adverse patient effects were reported.The device has been returned and analyzed.Additional information received indicates that the patient with this lead experienced diaphragmatic stimulation which caused pain.The patient received morphine as treatment.The patient reported that they had previously experienced the issue of diaphragmatic stimulation, so pacing had been disabled for a lead, with the other lead still pacing.The crt-p system has associated non boston scientific leads as well as boston scientific lead.The lead responsible for the diaphragmatic stimulation was not specified.When interrogated, it was discovered this crt-p had entered safety mode.The crt-p system was subsequently explanted.No additional adverse patient effects were reported.

• Brand Name: INVIVE?
• Common Device Name: 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: 21891680
• Report Number: 2124215-2025-25763
• Device Sequence Number: 18190223
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: (01)00802526536632(17)160717
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

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: 07/17/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 106980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 03/01/2026
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 07/01/2025; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2016-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male