PRIMEADVANCED
Report
- Report Number
- 3004209178-2013-07692
- Event Type
- Malfunction
- Date Received
- May 15, 2013
- Report Date
- April 15, 2013
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
IT WAS STATED, THE PATIENT EXPERIENCED A POWER ON RESET (POR) CODE ON THEIR PATIENT PROGRAMMER. IT WAS STATED, THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION AND THAT THE PROGRAMMER WAS "ACTING UP" AND WAS HAVING A HARD TIME TURNING ON THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE PROGRAMMER. IT WAS NOTED, THE PATIENT ONLY TURNED ON THE INS FOR 20-30 MINUTES WHEN SHE HAD PAIN THEN TURNED IT OFF. IT WAS ALSO NOTED ELECTRODES 8 AND 9 HAD HIGH IMPEDANCES BUT THESE WERE NOT USED IN PROGRAMMING. IT WAS STATED, THE PATIENT HAD AN X-RAY A FEW DAYS BEFORE REPORT. REPORTEDLY, STIMULATION WAS HELPING PATIENT WITH PAIN AND WHEN THE INS WAS ON, THEY DIDN'T HAVE ANY PROBLEMS WITH STIMULATION. IT WAS LATER REPORTED THAT THE PATIENT WAS HAVING PROBLEMS BECAUSE, THE BATTERIES IN THE PROGRAMMER WERE NEAR THE END OF LIFE. THE BATTERIES WERE REPLACED AND "ALL WAS FINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214708 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |