EMBLEM S-ICD
Report
- Report Number
- 2124215-2024-58464
- Event Type
- Injury
- Date Received
- September 18, 2024
- Date of Event
- October 1, 2020
- Report Date
- December 17, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- PMA / PMN Number
- P110042/S077
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE RETURNED ELECTRODE WAS THOROUGHLY INSPECTED AND ANALYZED. RESISTANCE TESTS WERE COMPLETED TO ASSESS ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY AND ELECTRODE BODY FOUND NO ANOMALIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY ELECTRODE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.
IT WAS REPORTED THAT THIS ELECTRODE AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED INCREASED SHOCK IMPEDANCE MEASUREMENTS FROM THE 77-92 OHMS RANGE AT IMPLANT, TO THE 120-150 OHMS RANGE BEGINNING APPROXIMATELY FOUR MONTHS POST IMPLANT. MEASUREMENTS REMAINED WITHIN THE 120-150 OHMS RANGE EVER SINCE. ADDITIONAL INFORMATION WAS RECEIVED SHOCK IMPEDANCE MEASUREMENTS CONTINUED TO INCREASE TO THE 200-216 OHMS RANGE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE DEVICE AND ELECTRODE WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RETURN OF THE PRODUCT HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.
IT WAS REPORTED THAT THIS ELECTRODE AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED INCREASED SHOCK IMPEDANCE MEASUREMENTS FROM THE 77-92 OHMS RANGE AT IMPLANT, TO THE 120-150 OHMS RANGE BEGINNING APPROXIMATELY FOUR MONTHS POST IMPLANT. MEASUREMENTS REMAINED WITHIN THE 120-150 OHMS RANGE EVER SINCE. ADDITIONAL INFORMATION WAS RECEIVED SHOCK IMPEDANCE MEASUREMENTS CONTINUED TO INCREASE TO THE 200-216 OHMS RANGE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE DEVICE AND ELECTRODE WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RETURN OF THE PRODUCT HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ROOT CAUSE OF THE HIGH SHOCK IMPEDANCE MEASUREMENTS WAS FELT TO BE DUE TO FAT BETWEEN THE ELECTRODE COIL AND THE STERNUM. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.
IT WAS REPORTED THAT THIS ELECTRODE AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED INCREASED SHOCK IMPEDANCE MEASUREMENTS FROM THE 77-92 OHMS RANGE AT IMPLANT, TO THE 120-150 OHMS RANGE BEGINNING APPROXIMATELY FOUR MONTHS POST IMPLANT. MEASUREMENTS REMAINED WITHIN THE 120-150 OHMS RANGE EVER SINCE. ADDITIONAL INFORMATION WAS RECEIVED SHOCK IMPEDANCE MEASUREMENTS CONTINUED TO INCREASE TO THE 200-216 OHMS RANGE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE DEVICE AND ELECTRODE WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RETURN OF THE PRODUCT HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ROOT CAUSE OF THE HIGH SHOCK IMPEDANCE MEASUREMENTS WAS FELT TO BE DUE TO FAT BETWEEN THE ELECTRODE COIL AND THE STERNUM. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2532749 | EMBLEM S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | 3501 | 163778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention| H |