MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number V173

Device Problem Failure to Capture (1081)

Patient Problem Asystole (4442)

Event Date 11/04/2022

Event Type  malfunction  

Event Description

It was reported that during a device changeout procedure, this cardiac resynchronization therapy pacemaker (crt-p) exhibited loss of capture (loc) in the right ventricular (rv) lead resulting in asystole for two seconds.There was no active electrocautery occurring at this time and the field representative stated that around the time this happened, the physician administered lidocaine prior to perform the skin incision.The representative also stated the event was observed both on the telemetry monitor as well as on the external defibrillator.Boston scientific technical services (ts) was consulted and upon review, signal artifact monitoring (sam) episodes were observed, however, these were not correlated to the timing of the asystole event.All lead measurements were stable prior to the procedure and measurements were within range after being connected to the new device.No additional adverse patient effects were reported.

Event Description

It was reported that during a device changeout procedure due to normal battery depletion (nbd), this cardiac resynchronization therapy pacemaker (crt-p) exhibited loss of capture (loc) in the right ventricular (rv) lead resulting in asystole for two seconds.There was no active electrocautery occurring at this time and the field representative stated that around the time this happened, the physician administered lidocaine prior to perform the skin incision.The representative also stated the event was observed both on the telemetry monitor as well as on the external defibrillator.Boston scientific technical services (ts) was consulted and upon review, signal artifact monitoring (sam) episodes were observed, however, these were not correlated to the timing of the asystole event.All lead measurements were stable prior to the procedure and measurements were within range after being connected to the new device.No additional adverse patient effects were reported.This device has been received for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.The device was placed on a programmer but the device was not identified by it.The device data was insufficient to obtain a battery status and the device had no telemetry and no pacing output.Device case was removed and the obtained battery measurements confirmed to be too low to support device functions.The battery was sent to the battery lab for analysis and no battery related failure was found.The hybrid operated normally with external power.The cause of the depleted battery could not be established.

• Brand Name: INVIVE
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY 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: 15798172
• MDR Text Key: 303750957
• Report Number: 2124215-2022-47178
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

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: 02/18/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 103020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2013
• 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 Age: 71 YR
• Patient Sex: Male