MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A219

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Displays Incorrect Message (2591)

Patient Problems Erosion (1750); Unspecified Infection (1930); Electric Shock (2554)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

This device is still implanted and is not available for return.No further information concerning this report is currently available.This investigation will be updated should further information be provided.

Event Description

It was reported that this patient had received therapy where there was no sensing and a shock impedance that was low and out of range.The patient had twiddled their electrode back into the device pocket.The entire system was surgically abandoned due to erosion with infection.No additional adverse events were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed.External visual inspection noted arc marks on the case.Arcing damage like that seen with this device is consistent with an attempt to deliver therapy through a shorted lead system, which may cause internal damage to the circuitry.Review of the stored memory confirmed that the device exhibited long charge code.The out of range measurements indicates that there may be electrical damage.Based on inspection and analysis of this device, evidence indicates the device was damaged after delivering a shock through a shorted defibrillation lead.

Event Description

This supplemental report is being filled to include device explant information as well as device analysis.

Event Description

It was reported that this patient had received therapy where there was no sensing and a shock impedance that was low and out of range.The patient had twiddled their electrode back into the device pocket.The entire system was surgically abandoned due to erosion with infection.No additional adverse events were reported.This supplemental report is being filled to include device explant information as well as device analysis.This supplemental is being filed to provide updated evaluation coding.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed.External visual inspection noted arc marks on the case.Arcing damage like that seen with this device is consistent with an attempt to deliver therapy through a shorted lead system, which may cause internal damage to the circuitry.Review of the stored memory confirmed that the device exhibited long charge code.The out of range measurements indicates that there may be electrical damage.Based on inspection and analysis of this device, evidence indicates the device was damaged after delivering a shock through a shorted defibrillation lead.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 9550528
• MDR Text Key: 173710821
• Report Number: 2124215-2019-26848
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2021

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: 07/09/2021
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 250294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/10/2020; 10/06/2021
• Supplement Dates FDA Received: 04/10/2020; 12/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• 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 Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male