FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2244056
·
Received August 24, 2011
Report
- Report Number
- 3004209178-2011-06810
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Report Date
- August 9, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEADS WERE BROKEN AND IN THE WRONG LOCATION. THE PT WAS HAVING A REVISION SURGERY SOON. 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 | NA | Female | EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT # NKB000837V| IMPLANTED:| IMPLANTED:| LOT # 211470001| PROGRAMMER: MODEL 37743, LOT # NKE126905N| UNKNOWN CONVERSION TYPE: MODEL LEADN, | EXPLANTED:| EXTENSION: MODEL 37082, LOT # NKB000837V| UNKNOWN CONVERSION TYPE: MODEL LEADN,| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE126905N| IMPLANTED:| IMPLANTED:| LOT # 211470001 |