FDA Adverse Event
Death
Summary report: N
SPRINT FIDELIS
MDR report key: 2032976
·
Received March 29, 2011
Report
- Report Number
- 2649622-2011-04281
- Event Type
- Death
- Date Received
- March 29, 2011
- Date of Event
- May 11, 2009
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S029
- Removal / Correction Number
- Z-0070-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
AN ALLEGATION FROM AN ATTORNEY INDICATED THE LEAD HAD EXHIBITED A FRACTURE AND/OR WAS EXPLANTED. INFORMATION IDENTIFIED IN THE MANUFACTURE DATABASE NOTED THE PATIENT IS DECEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT FIDELIS | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6949 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death | 4193 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| 7297 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |