FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1983073
·
Received February 4, 2011
Report
- Report Number
- 3004209178-2011-00877
- Event Type
- Injury
- Date Received
- February 4, 2011
- Date of Event
- October 1, 2010
- Report Date
- November 16, 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
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THAT WHILE STIMULATION IS TURNED OFF, THE PATIENT STILL FEELS THE STIMULATION. PATIENT IS ALSO NOT RECEIVING ADEQUATE STIMULATION ON THE RIGHT SIDE. X-RAYS WERE DONE ON (B)(6) 2010 AND SHOWED ONE OF THE LEADS HAD SLIPPED UP TO THE T4-5 LEVEL. SURGICAL INTERVENTION WAS DONE ON (B)(6) 2010 TO PULL DOWN THE LEAD. PATIENT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention | LEAD: MODEL 3778, LOT# V480868001| LEAD: MODEL 3778, LOT# V467929009| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE154599N |