FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1854218
·
Received September 30, 2010
Report
- Report Number
- 3004209178-2010-07460
- Event Type
- Malfunction
- Date Received
- September 30, 2010
- Report Date
- September 2, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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
A PT EXPERIENCED STIMULATION IN THE WRONG LOCATION FOLLOWING THE IMPLANT PROCEDURE. IT WAS NOTED THAT THE DEVICE STIMULATION NEVER REALLY COVERED THE APPROPRIATE PAIN LOCATION, AND HIGH MEASURED IMPEDANCES HAD BEEN AN ISSUE FOR SOME TIME. IMPEDANCE MEASUREMENTS OVER 4000 OHMS WERE INDICATED. THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A F/U REPORT AS IT 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 | EXTENSION: MODEL 37083, LOT # NKC011445N| EXTENSION: MODEL 37083, LOT # NKC011077N| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT # NJD038948N| EXPLANTED:| LEAD: MODEL 3998, LOT # V017182| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: |