FDA Adverse Event
Malfunction
Summary report: N
GALLANT DR
MDR report key: 21178055
·
Received January 17, 2025
Report
- Report Number
- 2938836-2025-00001
- Event Type
- Malfunction
- Date Received
- January 17, 2025
- Date of Event
- December 30, 2024
- Report Date
- May 23, 2025
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NIK
- UDI-DI
- 05415067032003
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THIS SUPPLEMENTAL IS TO REPORT A CHANGE OF FDA REGISTRATION MANUFACTURING SITE INFORMATION FROM ST. JUDE MEDICAL INC. (AFD CAT-SUNNYVALE) 2938836 TO ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2017865.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED BLUETOOTH (BLE) TELEMETRY LOSS. IT WAS NOTED VIA MERLIN.NET THAT THE BLE ISSUE WAS RESOLVED, AND THE PATIENT IS CONNECTED AGAIN, HOWEVER, NO INFORMATION WAS PROVIDED AS TO WHAT MAY HAVE CAUSED THE BLE ISSUE OR HOW IT WAS RESOLVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1465146 | GALLANT DR | NO MATCH | NIK | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CDDRA500Q | P000200175 | 05415067032003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |