FDA Adverse Event
Injury
Summary report: N
EMBLEM S-ICD
MDR report key: 19602080
·
Received June 24, 2024
Report
- Report Number
- 2124215-2024-38752
- Event Type
- Injury
- Date Received
- June 24, 2024
- Date of Event
- June 5, 2024
- Report Date
- June 24, 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
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT, THIS ELECTRODE WAS DISLODGED AND THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED IF A DEFIBRILLATION THRESHOLD (DFT) TEST SHOULD BE PERFORMED. THE TECHNICAL SERVICES (TS) RECOMMENDED TO CONSIDER A NEW DFT TEST AS THERE IS UNCERTAINTY WHETHER THE DFT TEST WAS PERFORMED IN THIS ELECTRODE POSITION. A DFT WAS SCHEDULED AND PERFORMED AND SHOWED ADEQUATE CONVERSION. NO FURTHER ACTIONS WERE NOTED. THIS ELECTRODE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1104319 | EMBLEM S-ICD | SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) | LWS | BOSTON SCIENTIFIC CORPORATION | 3501 | 246818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |