MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

Model Number V173

Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

Patient Problems Presyncope (4410); Asystole (4442)

Event Date 10/02/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had reached elective replacement indicator (eri) and entered safety mode.It was noted that the patient was feeling fine until device interrogation, and experienced near syncope and approximately three seconds of asystole.It was suspected that the device had entered safety mode upon interrogation, and the patient was admitted to the hospital until the scheduled device replacement.The crt-p was explanted and replaced the next day.No additional adverse patient effects were reported.This crt-p was returned for analysis.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had reached elective replacement indicator (eri) and entered safety mode.It was noted that the patient was feeling fine until device interrogation and experienced near syncope and approximately three seconds of asystole.It was suspected that the device had entered safety mode upon interrogation, and the patient was admitted to the hospital until the scheduled device replacement.The crt-p was explanted and replaced the next day.No additional adverse patient effects were reported.This crt-p was returned for analysis.

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/determined it had undergone resets and that bradycardia therapy remained available.The system resets occurred during a telemetry session or while communicating with the latitude remote monitoring system 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 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.The product has been received for analysis.This report will be updated upon completion of analysis.

• Brand Name: INVIVE
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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: 17950093
• MDR Text Key: 325854948
• Report Number: 2124215-2023-57544
• Device Sequence Number: 1
• Product Code: NKE
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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: 05/13/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 103437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2013
• 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): Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male