MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D432

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

This product has been returned back from the field for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited code 1004 and 1007, indicative of a shock being delivered into a shorted lead, and the charge time being exceeded respectively.No intervention has been performed at this time and the icd remains in service.No adverse patient effects were reported.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited code 1004 and 1007, indicative of a shock being delivered into a shorted lead, and the charge time being exceeded respectively.Surgical intervention was later performed and the icd was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.High power visual inspection of the pg case and header noted arc marks on the case.Detailed analysis determined the device had no telemetry.The pg was damaged by a shock into a shorted lead condition.Analysis was able to confirm the allegation made against the device in the field.

• Brand Name: RESONATE EL ICD VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9637998
• MDR Text Key: 176631928
• Report Number: 2124215-2019-28678
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526588044
• UDI-Public: 00802526588044
• Combination Product (y/n): N
• PMA/PMN Number: P960040/S385
• 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: 04/06/2020

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: 10/30/2020
• Device Model Number: D432
• Device Catalogue Number: D432
• Device Lot Number: 244874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 04/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention