MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; IMPLANTABLE DEVICE

Model Number V173

Device Problem Pacing Problem (1439)

Patient Problem Insufficient Information (4580)

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that an interrogation was performed on this implanted cardiac resynchronization therapy pacemaker (crt-p) device on the morning that the device was scheduled to be replaced for normal battery depletion.The boston scientific representative indicated that during the interrogation, there were visible p-waves, but no pacing was observed and there was asystole for an estimated six beats.When the programmer wand was removed from the device, normal atrial and bi-ventricular device pacing resumed.Boston scientific technical services (ts) discussed that there is no clear reason why this might happen.Ts provided guidance to check the leads as they were implanted approximately ten years ago.The device was subsequently explanted and replaced as scheduled later that day, and the leads remain in-service.No patient symptoms or adverse patient effects were reported.

Manufacturer Narrative

The device has been returned for analysis.This report will be updated upon completion of analysis.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 occurred during a telemetry session and 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 an interrogation was performed on this implanted cardiac resynchronization therapy pacemaker (crt-p) device on the morning that the device was scheduled to be replaced for normal battery depletion.The boston scientific representative indicated that during the interrogation, there were visible p-waves, but no pacing was observed and there was asystole for an estimated six beats.When the programmer wand was removed from the device, normal atrial and bi-ventricular device pacing resumed.Boston scientific technical services (ts) discussed that there is no clear reason why this might happen.Ts provided guidance to check the leads as they were implanted approximately ten years ago.The device was subsequently explanted and replaced as scheduled later that day, and the leads remain in-service.No patient symptoms or adverse patient effects were reported.

• Brand Name: INVIVE
• Type of Device: IMPLANTABLE DEVICE
• 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: 12112973
• MDR Text Key: 260447705
• Report Number: 2124215-2021-14452
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/19/2014
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 102581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 07/03/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2018-2021
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Male