FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2062471
·
Received April 12, 2011
Report
- Report Number
- 3004209178-2011-02771
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 24, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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
IT WAS REPORTED THE PT EXPERIENCED INTERMITTENT STIMULATION FROM THEIR DEVICE THAT WOULD CHANGE WITH MOVEMENT. THE PT WAS REFERRED TO THEIR HEALTH CARE PROVIDER. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
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 | 45 YR | IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V271911008| PROGRAMMER: MODEL 37743, LOT# NKE146015N| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB058323V| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB058324V |