FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED
MDR report key: 3002200
·
Received March 13, 2013
Report
- Report Number
- 3004209178-2013-03646
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Report Date
- February 26, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 377860, LOT# V012070, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S DEVICE "HAD STOPPED WORKING AFTER IT WAS SHORTLY PUT IN." IT WAS NOTED THAT THE PATIENT WAS RECEIVING HELP AND THEY "WANTED TO JUST REPLACE THE BATTERY." NO FURTHER INFORMATION WAS GIVEN. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105082 | 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 |