EMBLEM S-ICD
Report
- Report Number
- 2124215-2023-53398
- Event Type
- Injury
- Date Received
- September 28, 2023
- Date of Event
- September 20, 2023
- Report Date
- November 6, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526599200
- PMA / PMN Number
- P110042/S077
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
CORRECTION TO DEVICE CODE TABLE, ADDED 2405: THERAPY DELIVERY DELIVERY/EFFECTIVENESS PROBLEM.
THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION IDENTIFIED NO ANOMALIES. THE DEVICE WAS ABLE TO BE INTERROGATED AND A MEMORY DOWNLOAD WAS PERFORMED SUCCESSFULLY. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO OUT OF RANGE MEASUREMENTS OR INTERRUPTIONS IN THERAPY OUTPUT. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. CORRECTION TO DEVICE CODE TABLE, ADDED 2405: THERAPY DELIVERY DELIVERY/EFFECTIVENESS PROBLEM.
IT WAS REPORTED THAT THIS ELECTRODE AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WERE IMPLANTED IN WHICH 3 DEFIBRILLATION THRESHOLD (DFT) TESTS WERE ATTEMPTED AND UNSUCCESSFUL. THIS PATIENT WAS BROUGHT BACK THE NEXT DAY FOR NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING AND ADDITIONAL DFT WAS PERFORMED AND UNSUCCESSFUL. THE ELECTRODE WAS REVISED AND MOVED AND DFT PERFORMED AFTER WHICH WAS AGAIN UNSUCCESSFUL. THE PHYSICIAN OPTED TO REMOVE THE S-ICD SYSTEM AND REPLACE WITH A TRANSVENOUS (TV) SYSTEM IN WHICH A SUCCESSFUL DFT WAS PERFORMED. THE TV SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS ELECTRODE AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WERE IMPLANTED IN WHICH 3 DEFIBRILLATION THRESHOLD (DFT) TESTS WERE ATTEMPTED AND UNSUCCESSFUL. THIS PATIENT WAS BROUGHT BACK THE NEXT DAY FOR NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING AND ADDITIONAL DFT WAS PERFORMED AND UNSUCCESSFUL. THE ELECTRODE WAS REVISED AND MOVED AND DFT PERFORMED AFTER WHICH WAS AGAIN UNSUCCESSFUL. THE PHYSICIAN OPTED TO REMOVE THE S-ICD SYSTEM AND REPLACE WITH A TRANSVENOUS (TV) SYSTEM IN WHICH A SUCCESSFUL DFT WAS PERFORMED. THE TV SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS ELECTRODE AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WERE IMPLANTED IN WHICH 3 DEFIBRILLATION THRESHOLD (DFT) TESTS WERE ATTEMPTED AND UNSUCCESSFUL. THIS PATIENT WAS BROUGHT BACK THE NEXT DAY FOR NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING AND ADDITIONAL DFT WAS PERFORMED AND UNSUCCESSFUL. THE ELECTRODE WAS REVISED AND MOVED AND DFT PERFORMED AFTER WHICH WAS AGAIN UNSUCCESSFUL. THE PHYSICIAN OPTED TO REMOVE THE S-ICD SYSTEM AND REPLACE WITH A TRANSVENOUS (TV) SYSTEM IN WHICH A SUCCESSFUL DFT WAS PERFORMED. THE TV SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2247080 | EMBLEM S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | 3501 | 247935 | 00802526599200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male | Hospitalization| R |