MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; IMPLANTABLE DEVICE

Model Number G125

Device Problems No Audible Alarm (1019); Failure to Capture (1081); Failure to Read Input Signal (1581); Telemetry Discrepancy (1629)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this patient underwent a scheduled device replacement procedure for normal battery depletion.This cardiac resynchronization therapy defibrillator (crt-d) device was implanted as the replacement device.However after pocket closure, telemetry connection to this device was lost when the physician was using electrocautery near the pocket.The device was unable to be interrogated using two different model programmers and subsequently received an out of range telemetry status.The boston scientific representative noted that they were able to easily interrogate the explanted device.The representative stated that one of the leads connected to the implanted device exhibited a downward deflection appearance but then the deflection changed to an upward appearance and the lower rate limit was 50 beats per minute.They also noted that the sinus rate is 60 beats per minute and they could not confirm if there was capture.Boston scientific technical services (ts) provided troubleshooting guidance to place a magnet over the device and the representative indicated there were no device tones as would be expected.The representative stated that the device had been taken out of storage mode.Ts indicated that this may not be a functioning device.The pocket was then reopened, the crt-d device was explanted and a new crt-d device of the same model number was successful implanted.No additional 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, a thorough evaluation of the product was performed.The device had no telemetry upon return.Engineering calculations confirmed the longevity of this device was not as expected.The device case was opened.An external power supply was connected to the device and the electrical current was monitored.During the monitoring process a high current condition was observed.It was then concluded that the cause of the reported allegations is a depleted battery caused by electrical overstress damage to the mixed-mode integrated circuits which caused an extremely high current drain, depleting the battery.The observed damage is not deemed to indicate product defect or malfunction, but likely occurred during normal use of the product.

Event Description

It was reported that this patient underwent a scheduled device replacement procedure for normal battery depletion.This cardiac resynchronization therapy defibrillator (crt-d) device was implanted as the replacement device.However after pocket closure, telemetry connection to this device was lost when the physician was using electrocautery near the pocket.The device was unable to be interrogated using two different model programmers and subsequently received an out of range telemetry status.The boston scientific representative noted that they were able to easily interrogate the explanted device.The representative stated that one of the leads connected to the implanted device exhibited a downward deflection appearance but then the deflection changed to an upward appearance and the lower rate limit was 50 beats per minute.They also noted that the sinus rate is 60 beats per minute and they could not confirm if there was capture.Boston scientific technical services (ts) provided troubleshooting guidance to place a magnet over the device and the representative indicated there were no device tones as would be expected.The representative stated that the device had been taken out of storage mode.Ts indicated that this may not be a funcitioning device.The pocket was then reopened, the crt-d device was explanted and a new crt-d device of the same model number was successful implanted.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM CRT-D
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12620428
• MDR Text Key: 276135747
• Report Number: 2124215-2021-24327
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589126
• UDI-Public: 00802526589126
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

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: Health Professional
• Device Expiration Date: 09/12/2021
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 136205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 11/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR