RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-06956
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Report Date
- April 8, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012-, PRODUCT TYPE EXTENSION; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
IT WAS NOTED THAT THE PATIENT WOULD JUST BE STANDING IN THE UPRIGHT POSITION AND THEIR STIMULATION WILL CUT OUT. WHEN THE PATIENT CHECKED THEIR DEVICE WITH THEIR PATIENT PROGRAMMER IT SHOWED THE DEVICE WAS STILL ON.
IT WAS REPORTED THAT THE PATIENT HAD INTERMITTENT LOSS OF STIMULATION. IT WAS NOTED THAT IT WAS UNKNOWN WHETHER THE INTERMITTENT LOSS OF STIMULATION WAS RELATED TO POSITION. IT WAS NOTED THAT PROGRAMMING PARAMETERS WERE ALSO UNKNOWN. TWO WEEKS LATER, IT WAS REPORTED THAT IMPEDANCES WERE ALL NORMAL. IT WAS NOTED THAT THE PATIENT'S PROGRAMMING WAS CHANGED 'A LITTLE' AND THE PATIENT WAS HAPPY WITH IT. IT WAS REPORTED THAT THE STIMULATION REMAINED ON WHEN THE PATIENT WAS STANDING STILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181028 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |