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

Model Number G124

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation noted evidence indicating difficulty may have been encountered fully inserting a is-4 lead into the header of this device resulting in oversensing with some pacing inhibition.Please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that during this device implant, the physician tried reconnecting the lead into the header several times.Noise oversensing with some pacing inhibition was noted, each time during isometric testing.Set screw issues were also noted.The physician said it did not feel quite right in the header.Thus, a new device was used, with no issues.No adverse patient effects were reported.This product has not been returned.This report will be updated, should additional information be received.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9972808
• MDR Text Key: 188066626
• Report Number: 2124215-2020-07544
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• UDI-Public: 00802526589102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2021
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 493597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR