FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1852164
·
Received September 29, 2010
Report
- Report Number
- 3004209178-2010-07440
- Event Type
- Malfunction
- Date Received
- September 29, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 2, 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
- OK, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PT WAS EXPERIENCING OVER STIMULATION WITH THEIR DEVICE TURNED ON. THE STIMULATION FELT WAS NOTED ALSO TO HAVE BEEN IN THE WRONG LOCATION. THE LEAD WAS FOUND TO HAVE MIGRATED, AS CONFIRMED VIA AN XRAY. THE PT DID NOT KNOW OF ANY PRIOR INCIDENT, SUCH AS A FALL THAT COULD HAVE CONTRIBUTED TO THE ISSUE. LATER, THE PT WAS NOTED AS DOING FINE WITH NO ISSUES. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | 86 YR | IMPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT# N235359| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V396428004| PROGRAMMER: MODEL 37743, LOT# NKE138862N| EXPLANTED:| IMPLANTED:| IMPLANTED: |