FDA Adverse Event
Malfunction
Summary report: N
PRIMEADVANCED
MDR report key: 2661219
·
Received July 19, 2012
Report
- Report Number
- 3004209178-2012-05818
- Event Type
- Malfunction
- Date Received
- July 19, 2012
- Report Date
- June 22, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# V113343, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION DURING CAT SCANS IN THE PAST. THE PATIENT HAD NO RECENT CAT SCANS DONE. THE PATIENT WAS CONCERNED MOVING FORWARD WITH OTHER MEDICAL PROCEDURES AS SHE HAD BEEN TOLD IN THE PAST SHE WOULDN'T FEEL ANYTHING EVEN WITH THE DEVICE OFF, BUT SHE HAD. THE PATIENT WAS NOT HAVING ANY ISSUES WITH THE CURRENT SYSTEM, BUT STATED THAT SHE WAS NOT ONE OF THE ONE'S THAT RECEIVED EXCELLENT PAIN RELIEF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |