MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G124

Device Problems Failure to Capture (1081); High impedance (1291); High Capture Threshold (3266)

Patient Problems Syncope (1610); No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2020

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and two epicardial left ventricular (lv) leads were was implanted a few months ago along with the existing right ventricular (rv) lead.Now a few months later, this rv lead had an alert for high out of range pacing impedances greater than 3000 ohms.Review of the device report found a quick rise in impedances that have stayed steadily high.An x-ray was performed and appears to show full insertion of the rv lead, and the presenting egm shows a very clean and appropriate shock egm.Technical services suggested further troubleshooting.The device remains in-service.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and two epicardial left ventricular (lv) leads were was implanted a few months ago along with the existing right ventricular (rv) lead.Now a few months later, this rv lead had an alert for high out of range pacing impedances greater than 3000 ohms.Review of the device report found a quick rise in impedances that have stayed steadily high.An x-ray was performed and appears to show full insertion of the rv lead, and the presenting egm shows a very clean and appropriate shock egm.Technical services suggested further troubleshooting.The device remains in-service.No adverse patient effects were reported.Additional information was received that this rv lead had continued high pacing impedances and recently observed loss of capture at maximum output where the patient experienced syncope.This high impedance started after the epicardial leads were placed a few months ago.An additional surgical procedure was performed where it was discovered that the setscrew of the device was accidently not tightened down when device/epicardial leads were implanted a few months ago.The setscrew was tightened and the issue has since resolved.

• Brand Name: MOMENTUM CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10675594
• MDR Text Key: 211249986
• Report Number: 2124215-2020-20686
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• UDI-Public: 00802526589102
• 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
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/24/2022
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 499433
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR