FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1864457
·
Received October 6, 2010
Report
- Report Number
- 3004209178-2010-07642
- Event Type
- Injury
- Date Received
- October 6, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 9, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- 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
IT WAS REPORTED THAT A PHYSICIAN BELIEVED, A PATIENT BECAME INFECTED AFTER A SPINAL CORD STIMULATOR WAS IMPLANTED. ADDITIONAL INFORMATION 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 | 60 YR | EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB004787V| IMPLANTED:| LEAD: MODEL 3998, LOT# V378107| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE144892N| IMPLANTED: |