FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME
MDR report key: 1872500
·
Received October 12, 2010
Report
- Report Number
- 3004209178-2010-07827
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 14, 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
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PT HAD A LOSS OF THERAPEUTIC EFFECT. THE AREA OF THE PT'S BODY EFFECTED BY THE ISSUE WAS BOTH THEIR LEGS AND FEET. THE PT STATED THAT IT FELT LIKE THEIR STIMULATOR/DEVICE WAS NOT WORKING AT ALL. IT WAS NOTED THAT THERE WAS NO KNOWN ACCIDENT OR INCIDENT THAT OCCURRED, THAT COULD BE RELATED TO THE ISSUE. THE PT'S OUTCOME WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37701 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | IMPLANTED:| LEAD: MODEL 3776, LOT#: V006636| PROGRAMMER: MODEL 37742, LOT#: NJD021995N| EXPLANTED:| EXPLANTED:| IMPLANTED: |