FDA Adverse Event
Malfunction
Summary report: N
SPRINT FIDELIS
MDR report key: 1636765
·
Received March 5, 2010
Report
- Report Number
- 1636765
- Event Type
- Malfunction
- Date Received
- March 5, 2010
- Date of Event
- November 27, 2009
- Report Date
- February 3, 2010
- Manufacturer
- MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
Narratives
Description of Event or Problem · 1
THE PATIENT WAS AT HOME WHEN THEIR ICD FIRED X 10. EMS WAS CALLED. THE ICD SHOCKED AN ADDITIONAL 8 TIMES WHICH WAS WITNESSED BY EMS. THE PATIENT COMPLAINED OF PALPITATIONS BUT DENIED CHEST PAIN AND SHORTNESS OF BREATH. THE ICD WAS INTERROGATED IN THE ED. IT INDICATED THAT NOISE WAS NOTED ON THE STORED ELECTROGRAMS (EGMS) CONSISTENT WITH A SPRINT FIDELIS LEAD FRACTURE. THE SPRINT FIDELIS LEAD WAS CAPPED AND REMAINS INSITU. ANOTHER LEAD WAS IMPLANTED. THE PATIENT'S OUTCOME WAS SATISFACTORY. MANUFACTURER RESPONSE (AS PER REPORTER) FOR LEAD, SPRINT FIDELISNO RESPONSE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT FIDELIS | LEAD, DEFIBRILLATION | LWS | MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT | 6949 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |