FDA Adverse Event Malfunction Summary report: N

EMBLEM S-ICD

MDR report key: 11788151 · Received May 6, 2021

Report

Report Number
2124215-2021-10410
Event Type
Malfunction
Date Received
May 6, 2021
Date of Event
February 25, 2021
Report Date
May 6, 2021
Manufacturer
BOSTON SCIENTIFIC CORPORATION
Product Code
LWS
UDI-DI
00802526599200
PMA / PMN Number
P110042/S077
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DID NOT CONVERT THE ARRHYTHMIA DURING DEFIBRILLATION THRESHOLD (DFT) TESTING AT IMPLANT AND IMPEDANCE MEASUREMENTS WERE HIGH AROUND 180 OHMS. DURING THE PROCEDURE THE ELECTRODE WAS REPOSITIONED AND THE IMPEDANCE DECREASED TO 130 OHMS. HOWEVER, THE ARRHYTHMIA STILL WAS NOT CONVERTED WITH ANOTHER DFT TEST. ONE MONTH LATER THE PATIENT WAS BROUGHT BACK INTO THE OFFICE TO DISCUSS HAVING AN ADDITIONAL DFT TEST. TECHNICAL SERVICES (TS) WAS CONSULTED AGAIN AND DISCUSSED THE POSITION OF THE DEVICE AND ELECTRODE. IT WAS NOTED THAT IF DFT TESTING DID NOT CONVERT THE ARRHYTHMIA DURING THE NEXT DFT TEST, THE PHYSICIAN WOULD CONSIDER REVISING THE ELECTRODE. TS DISCUSSED THE OPTION OF REPOSITIONING THE S-ICD AT THE SAME TIME AS BASED UPON IMAGING, IT APPEARED TO BE IMPLANTED MID-LINE AND MAY HAVE BETTER CONVERSION IF POSITIONED SLIGHTLY MORE POSTERIOR. THE FIELD REPRESENTATIVE REACHED OUT THE CLINIC AND DETERMINED THE PATIENT HAS NOT YET UNDER GONE A SECOND DFT TEST AT THIS TIME DUE TO PERSONAL CHOICE. THE S-ICD AND ELECTRODE REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
684734 EMBLEM S-ICD IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 3501 160077 00802526599200

Patients

Seq Age Sex Outcome Treatment
1 41 YR