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

Model Number G125

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 09/05/2019

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 during a routine check-up, this cardiac resynchronization therapy defibrillator (crt-d) device was interrogated and found to be in safety mode with limited critical therapy still available.Boston scientific technical services (ts) provided guidance that the device needs to be replaced.Subsequently, this device was explanted and replaced.The patient reported feeling awful and also sore following the replacement procedure.

Event Description

This supplemental report is being filed based on completion of device analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety core and that both brady and tachy therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.

• 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: 9168252
• MDR Text Key: 161609902
• Report Number: 2124215-2019-20398
• 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
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

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: Lay User/Patient
• Device Expiration Date: 02/09/2021
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 131977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 01/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR