FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 827371
·
Received March 9, 2007
Report
- Report Number
- 3004209178-2007-00841
- Event Type
- Injury
- Date Received
- March 9, 2007
- Date of Event
- February 10, 2007
- Report Date
- February 12, 2007
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MFR REP REPORTED THE DEVICE SYSTEM WAS REMOVED DUE TO INFECTION. THE DEVICES WERE NOT RETURNED TO THE MFR FOR ANALYSIS. ADD'L INFO HAS BEEN REQUESTED BY MEDTRONIC FROM THE HEALTH CARE PROFESSIONAL REGARDING THE REPORTED EVENT. A SUPPLEMENTAL MDR F/U REPORT WILL BE SENT TO FDA IF ADD'L INFO IS REC'D.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention | EXTENSION MODEL 37083 LOT# NKC010170N IMPLANTED:| EXPLANTED:| LEAD MODEL 3998 LOT# V014426 IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION MODEL 37083 LOT# NKC010250N IMPLANTED: |