PRIMEADVANCED
Report
- Report Number
- 3004209178-2013-07917
- Event Type
- Malfunction
- Date Received
- May 20, 2013
- Report Date
- April 30, 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
- WA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708360 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3550-14 LOT# N301927, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 3708160 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3986A45 LOT# N301363, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 355531 LOT# N310717, IMPLANTED: 2011 (B)(6), PRODUCT TYPE SCREENING DEVICE. (B)(4).
IT WAS REPORTED, THE PATIENT CAN FEEL STIMULATION IN THEIR LEG AND IT¿S TWITCHING.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION 6 MONTHS AGO FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) DUE HAVING THE AMPLITUDE TURNED UP TOO HIGH. IT WAS ALSO REPORTED THAT THE PATIENT WOULD SOMETIMES ¿SHAKE¿ WHEN THE INS WAS ON AND THAT THEY FELT THIS WAS DUE TO THE PULSE WIDTH OR RATE ARE TOO HIGH. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222203 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |