FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2160821
·
Received July 7, 2011
Report
- Report Number
- 3004209178-2011-05200
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 14, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED BLISTERING ON HIS SKIN AROUND HIS IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THE INS WAS EXPLANTED AND REPLACED. THE INS POCKET FULLY HEALED AND NO FURTHER REDNESS OR BLISTERING WAS PRESENT. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L 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 | 35 YR | Required Intervention | IMPLANTED:| LOT# NKF729165H| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA148231N| PROGRAMMER: MODEL 37742, LOT# NJD050608N| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC016362N| LEAD: MODEL 39286-65, LOT# V538771026| IMPLANTABLE NEURO STIMULATOR: MODEL 37712,| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE159414N| EXPLANTED:| LEAD: MODEL 3999, LOT# J0511411V| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC014415N |