FDA Adverse Event
Malfunction
Summary report: N
SPRINT FIDELIS
MDR report key: 17516953
·
Received August 11, 2023
Report
- Report Number
- MW5123902
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Report Date
- September 1, 2011
- Manufacturer
- MEDTRONIC
- Product Code
- LWS
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
TECHNICAL SERVICES RECEIVED A CALL ON 07/25/2011 FROM SALES REP. WHEN LOGGING CALL NOTED LOW RV INTRINSIC AMPLITUDE 0.8 MV. NO PHYSICIAN OR HOSPITAL KNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 564734 | SPRINT FIDELIS | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | MEDTRONIC | 6949 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |