FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1822580
·
Received August 27, 2010
Report
- Report Number
- 3004209178-2010-06546
- Event Type
- Injury
- Date Received
- August 27, 2010
- Date of Event
- February 23, 2010
- Report Date
- July 30, 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
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING REPROGRAMMING. THE NEUROSTIMULATOR WAS REPLACED AND THE PT RECOVERED WITHOUT SEQUELAE. ADDITIONAL INFORMATION WAS REQUESTED.
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 | 51 YR | Required Intervention | IMPLANTED:| LEAD: MODEL 3778, LOT# V248269035| LEAD: MODEL 3487A, LOT# V228165| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB001837V| LEAD: MODEL 3487A, LOT# V228165| PROGRAMMER: MODEL 37743, LOT# NKE126205N| EXPLANTED:| IMPLANTED: |