RESTORE ADVANCED
Report
- Report Number
- 3004209178-2013-06917
- Event Type
- Malfunction
- Date Received
- April 25, 2013
- Report Date
- April 16, 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
- AZ, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3998, LOT# V042627, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).
ADDITIONAL INFORMATION FOUND IT WAS FURTHER REPORTED THE FALL HAPPENED MANY MONTHS BEFORE THE REPORTED SHOCKING STARTED TO OCCUR.
IT WAS REPORTED THE PATIENT EXPERIENCED 'SHOCKING IN HER FEET' FOR THE MONTH PRIOR TO REPORT. THE SHOCKING REPORTEDLY OCCURRED AFTER HAVING BEEN 'KNOCKED COMPLETELY OFF HER FEET DURING A DESERT CYCLONE.' IT WAS FURTHER STATED THAT WHEN SHE TURNED PROGRAM 1 'ALL THE WAY DOWN,' THE SHOCKING "STOPPED.' IT WAS ALSO NOTED THAT WHEN THE PATIENT INCREASED AMPLITUDE ON PROGRAM 2, SHE EXPERIENCED A HEADACHE. THE PATIENT WAS REDIRECTED TO HER HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE (B)(6) 2013 FROM A COMPANY REPRESENTATIVE AND HER CONCERNS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 178657 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |