PRIMEADVANCED
Report
- Report Number
- 3004209178-2013-04267
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Report Date
- March 11, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37702, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 37742, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD. (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS AGITATED. THE PATIENT WAS UNCOMFORTABLE BECAUSE THEY HAD 2 BATTERIES IN THEIR HIP.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF STIMULATION. IT WAS FURTHER REPORTED THAT THE PATIENT LAST FELT STIMULATION IN (B)(6) 2012. THE PATIENT STATED THAT HE FELT THE DEVICE WAS "DEFECTIVE" AND WISHED TO HAVE IT EXPLANTED. THE PATIENT WAS REDIRECTED TO HIS HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PLEASE SEE MFR. REPORT # 3004209178-2013-04266 FOR INFORMATION ON THE PATIENT'S OTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123095 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |