FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2231112
·
Received August 26, 2011
Report
- Report Number
- 3004209178-2011-06953
- Event Type
- Injury
- Date Received
- August 26, 2011
- Report Date
- August 13, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT HAD AN INFECTION WITH A BURNING SENSATION IN HER LEGS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER: MODEL 37743, LOT# NKE120836N I| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB048631V| EXTENSION: MODEL 37081, LOT# NJB048632V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 39565-30, LOT# N178736004| IMPLANTED: |