MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G447

Device Problems Premature Discharge of Battery (1057); Delayed Charge Time (2586)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that prior to implant when the field representative did a capacitor reform the charge time was noted at 45 second.A second capacitor reforms performed and the cardiac resynchronization therapy defibrillator (crt-d) indicated battery capacity depleted.Boston scientific technical services (ts) advised that the crt-d should not be implanted.The device was not implanted and was returned for analysis.

Manufacturer Narrative

A thorough evaluation of the device was performed upon receipt at our post market quality assurance laboratory.Visual inspection noted that both the inner and outer packaging was properly sealed.Review of device memory indicated that two charge timeout alerts (> 45 seconds) had been recorded.The device case was opened, and visual inspection noted that one of the two high voltage (hv) capacitors was slightly swollen.The hv capacitor was analyzed, and it was concluded that the hv capacitor experienced internal arcing caused by a low resistance pathway between anode and cathode plates within the capacitor.This capacitor issue impacted the device's ability to provide shock therapy because the hv capacitors could not be fully charged, but brady pacing, telemetry, and other device functionality remained available.

Event Description

This report is being filed to submit the analysis results.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9106652
• MDR Text Key: 159769649
• Report Number: 2124215-2019-18983
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• 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: 02/02/2020

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: Other
• Device Expiration Date: 05/26/2021
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 216542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 02/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1