FDA Adverse Event
Malfunction
Summary report: N
SPRINT FIDELIS
MDR report key: 1592321
·
Received January 22, 2010
Report
- Report Number
- 1592321
- Event Type
- Malfunction
- Date Received
- January 22, 2010
- Date of Event
- October 26, 2009
- Report Date
- December 23, 2009
- 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
DURING GENERATOR CHANGE AND UPGRADE TO BIVENTRICULAR ICD, THE CURRENT SPRINT FIDELIS LEAD WAS PALPATED ALONG ITS LENGTH. NOISE WAS NOTED ON THE VENTRICULAR SIDE WHEN PALPATING WHERE THE LEAD ENTERED THE VASCULATURE. THEREFORE, THE LEAD WAS EXPLANTED AND A NEW PACE/SENSE LEAD WAS PLACED. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS/SHOCKS RELATING TO THE LEAD. THE PATIENT'S OUTCOME WAS SATISFACTORY. MANUFACTURER RESPONSE (AS PER REPORTER) FOR LEAD, FIDELISNO CORRESPONDENCE 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 | 54 YR |