FDA Adverse Event
Summary report: N
SPRINT FIDELIS
MDR report key: 1150033
·
Received August 6, 2008
Report
- Report Number
- 1150033
- Date Received
- August 6, 2008
- Date of Event
- March 12, 2008
- Report Date
- August 6, 2008
- Manufacturer
- MEDTRONIC INC.
- Product Code
- LWS
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A PATIENT WITH A HISTORY OF DIABETES, RENAL FAILURE, CORONARY ARTERY DISEASE, ISCHEMIC CARDIOMYOPATHY WITH THE ABOVE 20% WAS ADMITTED FOR INCREASED FLUID RETENTION. IT WAS DETERMINED THE PATIENT NEEDED HIS PACEMAKER UPGRADED SO HE WAS TAKEN TO THE OPERATING ROOM AND THE MEDTRONIC MODEL 7288 ICD WAS REMOVED. A STYLET WAS PASSED DOWN THE FIDELIS ELECTRODE. THE ACTIVE FIXATION DEVICE WAS WITHDRAWN. USING A CONSTANT GENTLE TRACTION AND SOME ROTATION TORSION, WITH CONSTANT FLUOROSCOPIC MONITORING, THE SURGEON WAS ABLE TO REMOVE THIS LEAD IN ITS ENTIRETY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT FIDELIS | LEAD, ICD | LWS | MEDTRONIC INC. | 6949 | * | |
| 2 | INTRINSIC | ICD | LWS | MEDTRONIC INC. | 7288 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |