FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2160659
·
Received July 7, 2011
Report
- Report Number
- 3004209178-2011-05166
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 13, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS MOVED. THE REASON FOR THE MOVE WAS NOT PROVIDED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | IMPLANTED:| LEAD: MODEL 3487A, LOT# J0546326V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC010306N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC010305N| PROGRAMMER: MODEL 37742, LOT# NJD036209N| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0546326V |