PRIMEADVANCED
Report
- Report Number
- 3004209178-2013-06669
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- April 5, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THE PATIENT SAW AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE ON THEIR PATIENT PROGRAMMER A FEW MONTHS PRIOR TO REPORT. IT WAS ALSO REPORTED IT WAS UNKNOWN WHAT THE PATIENT'S STIMULATION STATUS WAS AND IF THEIR DEVICE HAD REACHED END OF SERVICE (EOS) YET. FIVE DAYS LATER, IT WAS REPORTED THE PATIENT RECEIVED AN ERI MESSAGE AND THEY STATED THEIR BATTERY HAD BEEN REPLACED JUST "6 MONTHS AGO OR SO". MANUFACTURER RECORDS SHOW THE PATIENT'S DEVICE WAS IMPLANTED NINE MONTHS PRIOR TO REPORT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER.
ADDITIONAL INFORMATION STATED THE PATIENT ¿RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED¿ AND THAT THEY HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013. IT WAS ALSO NOTED THE PATIENT ¿STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY, BUT HAD NOT SOUGHT FURTHER HELP.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171866 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |