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

Model Number A209

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Sense (1559); Low impedance (2285)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The explanted device was returned and is undergoing laboratory analysis.This report will be updated when analysis is complete.

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an appropriate shock for ventricular fibrillation (vf).Upon device interrogation, a red warning screen was displayed on the programmer.It was noted the shock impedance measurement for the delivered shock was low, out-of-range, at 5 ohms.A review of all sense vectors showed no signals.Error codes ct (charge time out) and lt (long charge time) were observed.Technical services discussed replacement of the device and electrode.The patient was hospitalized, and the s-icd system was explanted and replaced six days later.It was noted there was difficulty extracting the electrode via the xiphoid incision, and a surgeon was called in to assist.Subsequently, the electrode was removed successfully and a new s-icd system was implanted.No additional adverse patient effects were reported.The explanted products were returned for analysis.

Manufacturer Narrative

Prior to device decontamination, attempts to establish telemetry with the referenced s-icd were unsuccessful; thus, a memory download could not be performed.Visual inspection noted electrical overstress damage to the header; in addition, the header was cracked and a hole was found above the antenna on the lead barrel.The titanium case was opened, and visual inspection identified extensive electrical overstress damage to the internal components.Based on the reported clinical observations and results of laboratory analysis, engineers concluded that the electrical overstress occurred during delivery of high voltage therapy by this s-icd.Detailed investigation determined that this was due to a unique variation in the header assembly, which allowed for a very small pathway for moisture ingress, thus enabling shorting to occur.The extent of electrical overstress damage associated with the device's internal circuitry correlates with the red warning screen observed upon interrogation, as well as the low shock impedance measurements and error codes.

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an appropriate shock for ventricular fibrillation (vf).Upon device interrogation, a red warning screen was displayed on the programmer.It was noted the shock impedance measurement for the delivered shock was low, out-of-range, at 5 ohms.A review of all sense vectors showed no signals.Error codes ct (charge time out) and lt (long charge time) were observed.Technical services discussed replacement of the device and electrode.The patient was hospitalized, and the s-icd system was explanted and replaced six days later.It was noted there was difficulty extracting the electrode via the xiphoid incision, and a surgeon was called in to assist.Subsequently, the electrode was removed successfully and a new s-icd system was implanted.No additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• 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: 10687950
• MDR Text Key: 211629763
• Report Number: 2124215-2020-20842
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: 00802526544101
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S043
• 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: 02/02/2021

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: 09/03/2020
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 121520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 02/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention