EMBLEM S-ICD
Report
- Report Number
- 2124215-2024-00175
- Event Type
- Injury
- Date Received
- January 3, 2024
- Date of Event
- December 26, 2023
- Report Date
- July 23, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526544101
- PMA / PMN Number
- P110042/S043
- Removal / Correction Number
- Z-0935-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. ADDITIONALLY, REVIEW OF DEVICE MEMORY IDENTIFIED AN ERROR. THE ERROR RESULTED IN SOFTWARE RESETS PERFORMED IN AN ATTEMPT TO CORRECT AN IDENTIFIED MEMORY INCONSISTENCY. THE CAUSE OF THE MEMORY INCONSISTENCY WAS NOT ABLE TO BE DETERMINED THROUGH LABORATORY TESTING BUT WAS LIKELY THE RESULT OF A SINGLE EVENT UPSET CAUSED BY HIGH ENERGY PARTICLES/COSMIC RAYS, OR RADIOACTIVE DECAYING MATERIALS. IN MOST CASES THE S-ICD IS ABLE TO DETECT AND SELF-CORRECT TO MAINTAIN PRIMARY OPERATION.
DEVICE MEMORY ANALYSIS IDENTIFIED AN ERROR. THE ERROR RESULTED IN SOFTWARE RESETS PERFORMED IN AN ATTEMPT TO CORRECT AN IDENTIFIED MEMORY INCONSISTENCY. THE CAUSE OF THE MEMORY INCONSISTENCY WAS NOT ABLE TO BE DETERMINED BUT WAS LIKELY THE RESULT OF A SINGLE EVENT UPSET CAUSED BY HIGH ENERGY PARTICLES IN THE ENVIRONMENT. THESE PARTICLES TYPICALLY ARISE FROM THERAPEUTIC IONIZING RADIATION, NATURALLY OCCURRING HIGH ENERGY PARTICLES/COSMIC RAYS, OR RADIOACTIVE DECAYING MATERIALS. IN MOST CASES THE S-ICD IS ABLE TO DETECT AND SELF-CORRECT TO MAINTAIN PRIMARY OPERATION. TECHNICAL SERVICES ADVISED THE PATIENT SHOULD BE SEEN SO THAT THE PATIENT DATA COULD BE RESET, BUT THAT CRITICAL THERAPY REMAINED AVAILABLE.
IT WAS REPORTED THAT, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS FOUND BEEPING. UPON REVIEW, A WARM BOOT FAULT CODE WAS RECORDED. THE TECHNICAL SERVICES (TS) OBSERVED THAT THE DEVICE LOG FOR THE PATIENT HAD A SINGLE UPSET EVENT (SEU) LIKE SYMPTOM. THERE WAS NORMAL OPERATION POST THE ALERT, NONETHELESS THE TS CONSERVATIVELY RECOMMEND AN ADDITIONAL PATIENT INITIATED INTERROGATION (PII) AFTER THE DEVICE BEEPER IS RESET TO CONFIRM NORMAL BATTERY OPERATION AS THE DEVICE LOG WAS CONSUMED BY THE SEU SYMPTOM. THE ENGINEER ANALYSIS WAS PERFORMED, AND THE FIRMWARE LOGS SHOWED THAT THERE WAS AN EXCESSIVE NUMBER OF ERRORS DUE TO MEMORY CORRUPTION. THE ERRORS CEASED AFTER THE S-ICD RESET AND THE DEVICE HAS RESTORED TO NORMAL OPERATION. ADDITIONALLY, DATA SHOWS DEVICE POWER CONSUMPTION IS BEGINNING TO INCREASE IN A GRADUAL FASHION, CONSISTENT WITH HYDROGEN DEGRADATION OF A COMPONENT. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS FOUND BEEPING. UPON REVIEW, A WARM BOOT FAULT CODE WAS RECORDED. THE TECHNICAL SERVICES (TS) OBSERVED THAT THE DEVICE LOG FOR THE PATIENT HAD A SINGLE UPSET EVENT (SEU) LIKE SYMPTOM. THERE WAS NORMAL OPERATION POST THE ALERT, NONETHELESS THE TS CONSERVATIVELY RECOMMEND AN ADDITIONAL PATIENT INITIATED INTERROGATION (PII) AFTER THE DEVICE BEEPER IS RESET TO CONFIRM NORMAL BATTERY OPERATION AS THE DEVICE LOG WAS CONSUMED BY THE SEU SYMPTOM. THE ENGINEER ANALYSIS WAS PERFORMED, AND THE FIRMWARE LOGS SHOWED THAT THERE WAS AN EXCESSIVE NUMBER OF ERRORS DUE TO MEMORY CORRUPTION. THE ERRORS CEASED AFTER THE S-ICD RESET AND THE DEVICE HAS RESTORED TO NORMAL OPERATION. ADDITIONALLY, DATA SHOWS DEVICE POWER CONSUMPTION IS BEGINNING TO INCREASE IN A GRADUAL FASHION, CONSISTENT WITH HYDROGEN DEGRADATION OF A COMPONENT. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.IT WAS REPORTED THAT THE BATTERY OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED DEVICE REPLACEMENT. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS FOUND BEEPING. UPON REVIEW, A WARM BOOT FAULT CODE WAS RECORDED. THE TECHNICAL SERVICES (TS) OBSERVED THAT THE DEVICE LOG FOR THE PATIENT HAD A SINGLE UPSET EVENT (SEU) LIKE SYMPTOM. THERE WAS NORMAL OPERATION POST THE ALERT, NONETHELESS THE TS CONSERVATIVELY RECOMMEND AN ADDITIONAL PATIENT INITIATED INTERROGATION (PII) AFTER THE DEVICE BEEPER IS RESET TO CONFIRM NORMAL BATTERY OPERATION AS THE DEVICE LOG WAS CONSUMED BY THE SEU SYMPTOM. THE ENGINEER ANALYSIS WAS PERFORMED, AND THE FIRMWARE LOGS SHOWED THAT THERE WAS AN EXCESSIVE NUMBER OF ERRORS DUE TO MEMORY CORRUPTION. THE ERRORS CEASED AFTER THE S-ICD RESET AND THE DEVICE HAS RESTORED TO NORMAL OPERATION. ADDITIONALLY, DATA SHOWS DEVICE POWER CONSUMPTION IS BEGINNING TO INCREASE IN A GRADUAL FASHION, CONSISTENT WITH HYDROGEN DEGRADATION OF A COMPONENT. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. DEVICE MEMORY ANALYSIS IDENTIFIED AN ERROR. THE ERROR RESULTED IN SOFTWARE RESETS PERFORMED IN AN ATTEMPT TO CORRECT AN IDENTIFIED MEMORY INCONSISTENCY. THE CAUSE OF THE MEMORY INCONSISTENCY WAS NOT ABLE TO BE DETERMINED BUT WAS LIKELY THE RESULT OF A SINGLE EVENT UPSET CAUSED BY HIGH ENERGY PARTICLES IN THE ENVIRONMENT. THESE PARTICLES TYPICALLY ARISE FROM THERAPEUTIC IONIZING RADIATION, NATURALLY OCCURRING HIGH ENERGY PARTICLES/COSMIC RAYS, OR RADIOACTIVE DECAYING MATERIALS. IN MOST CASES THE S-ICD IS ABLE TO DETECT AND SELF-CORRECT TO MAINTAIN PRIMARY OPERATION. TECHNICAL SERVICES ADVISED THE PATIENT SHOULD BE SEEN SO THAT THE PATIENT DATA COULD BE RESET, BUT THAT CRITICAL THERAPY REMAINED AVAILABLE.
IT WAS REPORTED THAT, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS FOUND BEEPING. UPON REVIEW, A WARM BOOT FAULT CODE WAS RECORDED. THE TECHNICAL SERVICES (TS) OBSERVED THAT THE DEVICE LOG FOR THE PATIENT HAD A SINGLE UPSET EVENT (SEU) LIKE SYMPTOM. THERE WAS NORMAL OPERATION POST THE ALERT, NONETHELESS THE TS CONSERVATIVELY RECOMMEND AN ADDITIONAL PATIENT INITIATED INTERROGATION (PII) AFTER THE DEVICE BEEPER IS RESET TO CONFIRM NORMAL BATTERY OPERATION AS THE DEVICE LOG WAS CONSUMED BY THE SEU SYMPTOM. THE ENGINEER ANALYSIS WAS PERFORMED, AND THE FIRMWARE LOGS SHOWED THAT THERE WAS AN EXCESSIVE NUMBER OF ERRORS DUE TO MEMORY CORRUPTION. THE ERRORS CEASED AFTER THE S-ICD RESET AND THE DEVICE HAS RESTORED TO NORMAL OPERATION. ADDITIONALLY, DATA SHOWS DEVICE POWER CONSUMPTION IS BEGINNING TO INCREASE IN A GRADUAL FASHION, CONSISTENT WITH HYDROGEN DEGRADATION OF A COMPONENT. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS REPORTED THAT THE BATTERY OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED DEVICE REPLACEMENT. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS FOUND BEEPING. UPON REVIEW, A WARM BOOT FAULT CODE WAS RECORDED. THE TECHNICAL SERVICES (TS) OBSERVED THAT THE DEVICE LOG FOR THE PATIENT HAD A SINGLE UPSET EVENT (SEU) LIKE SYMPTOM. THERE WAS NORMAL OPERATION POST THE ALERT, NONETHELESS THE TS CONSERVATIVELY RECOMMEND AN ADDITIONAL PATIENT INITIATED INTERROGATION (PII) AFTER THE DEVICE BEEPER IS RESET TO CONFIRM NORMAL BATTERY OPERATION AS THE DEVICE LOG WAS CONSUMED BY THE SEU SYMPTOM. THE ENGINEER ANALYSIS WAS PERFORMED, AND THE FIRMWARE LOGS SHOWED THAT THERE WAS AN EXCESSIVE NUMBER OF ERRORS DUE TO MEMORY CORRUPTION. THE ERRORS CEASED AFTER THE S-ICD RESET AND THE DEVICE HAS RESTORED TO NORMAL OPERATION. ADDITIONALLY, DATA SHOWS DEVICE POWER CONSUMPTION IS BEGINNING TO INCREASE IN A GRADUAL FASHION, CONSISTENT WITH HYDROGEN DEGRADATION OF A COMPONENT. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS REPORTED THAT THE BATTERY OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED DEVICE REPLACEMENT. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 628543 | EMBLEM S-ICD | SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) | LWS | BOSTON SCIENTIFIC CORPORATION | A209 | 105895 | 00802526544101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Male | Hospitalization| R |