FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1924849
·
Received December 9, 2010
Report
- Report Number
- 3004209178-2010-10358
- Event Type
- Injury
- Date Received
- December 9, 2010
- Date of Event
- November 1, 2010
- Report Date
- December 1, 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
THE PT WAS UNABLE TO GET ANY RECHARGE EFFICIENCY BARS TO DARKEN. THE PT WAS SEEN IN CLINIC. THE FIELD REP WAS ALSO UNSUCCESSFUL GETTING COUPLING BETWEEN THE RECHARGER AND IMPLANTABLE NEUROSTIMULATOR. A NEW RECHARGER WAS USED, WHICH DIDN'T RESOLVE THE SITUATION. THE HCP BELIEVED THE DEVICE WAS IMPLANTED TOO DEEPLY OR FLIPPED. POCKET REVISION WAS PLANNED. ADDITIONAL INFO HAS BEEN REQUESTED. F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | 51 YR | Required Intervention | PROGRAMMER: MODEL 37743, LOT# NKE157382N| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39286-65, LOT# N214897001| ACCESSORY: MODEL 37752, LOT# NKA146610N |