PRIMEADVANCED
Report
- Report Number
- 3004209178-2013-03124
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Report Date
- February 7, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# V258459, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3888-33, LOT# V279838, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3888-33, LOT# V182141, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION. (B)(4).
(B)(4).
IT WAS CONFIRMED THAT ELECTRODES 0-3 AND 8 HAD OUT OF RANGE IMPEDANCES ON TWO OF THE THREE LEADS. THE DEVICE WAS REPROGRAMMED WITH THE LEADS THAT WERE FUNCTIONING. IT WAS NOTED THAT THE INS WAS NOT AT EOS YET. THE PATIENT'S DOCTOR WILL ADDRESS THE ISSUE AS NEEDED.
THE PATIENT REPORTED THAT SHE SAW THE MANUFACTURER REPRESENTATIVE TODAY AND TWO LEADS WERE "COMPLETELY FRIED OUT." THE PATIENT NOTED SHE WAS IN THE PROCESS OF "REDOING IT." ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84323 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |