EMBLEM MRI S-ICD
Report
- Report Number
- 2124215-2021-41032
- Event Type
- Injury
- Date Received
- February 4, 2022
- Date of Event
- March 26, 2020
- Report Date
- May 21, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526584404
- PMA / PMN Number
- P110042
- Removal / Correction Number
- Z-0936-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
EXPLANTED PERFORMED.
EXPLANTED PERFORMED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS S-ICD WAS THOROUGHLY INSPECTED AND ANALYZED. A HIGH CURRENT DRAIN WAS DETECTED, BUT THE BATTERY STILL SUPPORTED FULL DEVICE FUNCTION. DETAILED ANALYSIS CONFIRMED THE IDENTIFIED HIGH CURRENT DRAIN WAS A RESULT OF A COMPROMISED CAPACITOR. THIS RESULTED IN THE OBSERVED PREMATURE BATTERY DEPLETION. IT WAS DETERMINED THAT THE CAPACITOR WAS COMPROMISED DUE TO THE PRESENCE OF EXCESS HYDROGEN IN THE DEVICE CASE. BOSTON SCIENTIFIC ISSUED A FIELD SAFETY NOTICE REGARDING A SUBSET OF EMBLEM DEVICES THAT HAVE A POTENTIAL OF EXHIBITING THIS BEHAVIOR. THIS PARTICULAR DEVICE IS INCLUDED IN THE EMBLEM S-ICD ACCELERATED DEPLETION ADVISORY POPULATION.
IT WAS REPORTED THAT PRIOR TO AN LEFT VENTRICULAR ASSIST DEVICE CHANGE OUT, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS INTERROGATED AND EXHIBITED A CC CODE INDICATIVE OF CORRUPTION OF CALIBRATION CONSTANTS. DATA WAS SENT FOR ANALYSIS WHICH CONFIRMED THE OBSERVED CC CODE HOWEVER IT HAD CORRECTED. THERE WERE NO OTHER DEVICE ANOMALIES NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT PRIOR TO AN LEFT VENTRICULAR ASSIST DEVICE CHANGE OUT, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS INTERROGATED AND EXHIBITED A CC CODE INDICATIVE OF CORRUPTION OF CALIBRATION CONSTANTS. DATA WAS SENT FOR ANALYSIS WHICH CONFIRMED THE OBSERVED CC CODE HOWEVER IT HAD CORRECTED. THERE WERE NO OTHER DEVICE ANOMALIES NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
0IT WAS REPORTED THAT PRIOR TO AN LEFT VENTRICULAR ASSIST DEVICE CHANGE OUT, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS INTERROGATED AND EXHIBITED A CC CODE INDICATIVE OF CORRUPTION OF CALIBRATION CONSTANTS. DATA WAS SENT FOR ANALYSIS WHICH CONFIRMED THE OBSERVED CC CODE HOWEVER WAS CORRECTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS S-ICD WAS INTERROGATED AND SHOWED BATTERY DEPLETION. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE S-ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT PRIOR TO AN LEFT VENTRICULAR ASSIST DEVICE CHANGE OUT, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS INTERROGATED AND EXHIBITED A CC CODE INDICATIVE OF CORRUPTION OF CALIBRATION CONSTANTS. DATA WAS SENT FOR ANALYSIS WHICH CONFIRMED THE OBSERVED CC CODE HOWEVER WAS CORRECTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS S-ICD WAS INTERROGATED AND SHOWED BATTERY DEPLETION. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE S-ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1402339 | EMBLEM MRI S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | BOSTON SCIENTIFIC CORPORATION | A219 | 214636 | 00802526584404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Male | Hospitalization| R |