FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2230438
·
Received August 15, 2011
Report
- Report Number
- 3004209178-2011-06387
- Event Type
- Injury
- Date Received
- August 15, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 22, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2011 DUE TO A STAPH INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | LEAD: MODEL 3777, LOT# V632811007| ACCESSORY: MODEL 37752, LOT# NKA152540N| STIM ACCESSORY: MODEL 3550-29 LOT# N235359| STIM ACCESSORY: MODEL 37092, LOT# 279260001| PROGRAMMER: MODEL 37743, LOT# NKE166994N| IMPLANTED:| EXPLANTED: |