FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1924807
·
Received December 7, 2010
Report
- Report Number
- 3004209178-2010-10289
- Event Type
- Injury
- Date Received
- December 7, 2010
- Date of Event
- November 4, 2010
- Report Date
- November 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
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD LAST RECHARGED THE DEVICE ON (B)(6) 2010. IN (B)(6) 2010, TWO UNSUCCESSFUL PHYSICIAN MODE RECHARGES (PMR) WERE DONE. IT WAS VERIFIED THE DEVICE WAS NOT FLIPPED. THE DEVICE WAS REPLACED. THE PT WAS DOING GREAT AND WAS MUCH HAPPIER WITH 6 DIFFERENT PROGRAMS TO USE FOR STIMULATION.
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 | 26 YR | Required Intervention | ACCESSORY: MODEL 37752, LOT# NKA119490N| LEAD: MODEL 3778, LOT# V180584017| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V180584018| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT#NKE118666N| EXPLANTED: |