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

Model Number G124

Device Problem Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2020

Event Type  malfunction  

Event Description

It was reported that during a replacement procedure due to normal battery depletion, the physician experienced difficulty in tightening the setscrew of this device to the right ventricular (rv) lead.The physician elected to exchange this device to resolve the event and the procedure was successfully completed.The patient was stable with no adverse consequences.The device is expected for analysis, but has not yet been received.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted a missing rv setscrew.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the missing rv setscrew or reported tightening difficulties.

Event Description

It was reported that during a replacement procedure due to normal battery depletion, the physician experienced difficulty in tightening the setscrew of this device to the right ventricular (rv) lead.The physician elected to exchange this device to resolve the event and the procedure was successfully completed.The patient was stable with no adverse effects reported.The device was received for analysis.

• 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: 11152896
• MDR Text Key: 226242330
• Report Number: 2124215-2020-28059
• Device Sequence Number: 1
• Product Code: NIK
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2022
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 498711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 05/25/2021
• Patient Sequence Number: 1
• Patient Age: 72 YR