FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1822441
·
Received August 26, 2010
Report
- Report Number
- 3004209178-2010-06467
- Event Type
- Injury
- Date Received
- August 26, 2010
- Date of Event
- May 6, 2010
- Report Date
- July 29, 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
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
THE PT ACHIEVED SOME PAIN RELIEF BUT STILL HAD BEEN UNABLE TO EAT AND PREVENTING HER FROM LOSING MORE WEIGHT. SURGICAL REPOSITIONING OF THE DEVICE WAS PERFORMED AND THE PT RECOVERED WITHOUT SEQUELAE.
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 | 28 YR | Female | Hospitalization| R | ACCESSORY: MODEL 37752, LOT# NKA134332N| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V295214009| LEAD: MODEL 3778, LOT# V368065038| PROGRAMMER: MODEL 37743, LOT# NKE136616N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V295214009| LEAD: MODEL 3778, LOT# V368065038| ACCESSORY: MODEL 37752, LOT# NKA134332N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE136616N |