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

Model Number V173

Device Problems Signal Artifact/Noise (1036); Premature Discharge of Battery (1057); Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)

Patient Problems Chest Pain (1776); Device Overstimulation of Tissue (1991); Asystole (4442)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency room with chest pain.Upon interrogation, it was determined that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode and it was suspected that the battery was depleting prematurely.This crt-p also exhibited unipolar pacing oversensing and pacing inhibition with greater than two seconds of asystole.In addition, the patient was experiencing muscle/pocket stimulation.This crt-p was explanted and replaced.It was noted that intravenous antibiotics were administered.No additional adverse patient effects were reported.This crt-p is expected to be returned for analysis.

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.-- 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 due to system resets.The system resets caused the device to enter 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 related to telemetry attempts 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 Description

It was reported that the patient presented to the emergency room with chest pain.Upon interrogation, it was determined that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode and it was suspected that the battery was depleting prematurely.This crt-p also exhibited unipolar pacing oversensing and pacing inhibition with greater than two seconds of asystole.In addition, the patient was experiencing muscle/pocket stimulation.This crt-p was explanted and replaced.It was noted that intravenous antibiotics were administered.No additional adverse patient effects were reported.This crt-p is expected to be returned for 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: 14529688
• MDR Text Key: 292957683
• Report Number: 2124215-2022-16539
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

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: 01/08/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 105330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 08/17/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female