MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D121

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285); Device Displays Incorrect Message (2591)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 12/11/2019

Event Type  malfunction  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited two codes on device interrogation.The codes indicated a shock lead short, and charge time exceeded.Boston scientific technical services (ts) discussed the device attempted to deliver a shock, however, low out-of-range (oor) shock impedances were detected due to a potential lead issue and the energy found an alternative pathway and likely damaged the device.Subsequently, a revision procedure was performed.The icd was explanted and replaced.Defibrillation threshold (dft) testing was performed in the single coil configuration, and the shock impedances were 68 ohms.Then dft testing was performed again in the dual coil configuration, and a code 1004, shorted shock lead was detected.This icd was removed/replaced prior to pocket closure.The proximal coil of the right ventricular (rv) lead was surgically abandoned.Another icd was implanted and dft testing was performed in the single coil configuration.The shock impedances were 69 ohms.This icd was successfully implanted and the rv lead remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection of the device identified no anomalies.Review of device memory found a shorted lead error code 1004 was recorded on december 11, 2019, before the charge time exceeded error code 1007 was recorded.An x-ray of the device revealed that the internal high voltage fuse was damaged (i.E., no longer intact).The damage to the fuse most likely occurred during delivery of the shock that resulted in the shorted shock lead error.The damage to the high voltage fuse prevented any subsequent charging of the high voltage capacitors and delivery of shock therapy.As a result, the high voltage charge attempt caused the device to declare eri because it could not successfully complete charging within 30 seconds, despite the fact that significant battery voltage and capacity remained.

Event Description

This supplemental report is being filed as the device evaluation was completed.

• Brand Name: MOMENTUM EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9550872
• MDR Text Key: 174170398
• Report Number: 2124215-2020-00089
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526587726
• UDI-Public: 00802526587726
• Combination Product (y/n): N
• PMA/PMN Number: P960040/S385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

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: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: D121
• Device Catalogue Number: D121
• Device Lot Number: 214924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 04/10/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR