FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1993876
·
Received February 11, 2011
Report
- Report Number
- 3004209178-2011-01068
- Event Type
- Injury
- Date Received
- February 11, 2011
- Report Date
- January 26, 2011
- 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
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT DEVELOPED AN INFECTION AND THE INS WAS CLOSE TO ERODING THROUGH THE SKIN. THE INS WAS GOING TO BE MOVED. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXTENSION: MODEL 37081, LOT# NJB057138V| EXPLANTED:| LEAD: MODEL 3778, LOT# V461166033| LEAD: MODEL 3778, LOT# V461166034| EXTENSION: MODEL 37081, LOT# NJB058241V| PROGRAMMER: MODEL 37743, LOT# NKE151818N| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED: |