FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1902272
·
Received November 15, 2010
Report
- Report Number
- 3004209178-2010-09468
- Event Type
- Injury
- Date Received
- November 15, 2010
- Date of Event
- October 28, 2010
- Report Date
- October 28, 2010
- 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
RECEIVED INFORMATION PATIENT HAD BEEN IN A CAR ACCIDENT AND FOR SEVERAL MONTHS AFTERWARDS EXPERIENCED DIFFICULTY RECHARGING AND COUPLING THE PROGRAMMER. IT WAS THOUGHT THE INS HAD SLIPPED DEEPER SUBCUTANEOUSLY. PATIENT UNDERWENT A POCKET REVISION. THE PATIENT WAS REPORTED TO HAVE NO INJURY AND RECOVERED WITHOUT SEQUELA.
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 | 37 YR | Required Intervention | IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE113598N| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA119063N| EXTENSION: MODEL 37081, LOT# NJB044604V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB045541V| LEAD: MODEL 39565-30, LOT# N158264007 |