FDA Adverse Event
Malfunction
Summary report: N
PRIMEADVANCED
MDR report key: 2538221
·
Received April 17, 2012
Report
- Report Number
- 3004209178-2012-02408
- Event Type
- Malfunction
- Date Received
- April 17, 2012
- Date of Event
- March 22, 2012
- Report Date
- March 22, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID (B)(4) LOT#, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED. PRODUCT TYP LEAD; PRODUCT ID (B)(4), SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS IMPLANTED BEYOND ITS USE-BY-DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |