RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-03323
- Event Type
- Malfunction
- Date Received
- March 5, 2013
- Report Date
- February 12, 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 MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
IT WAS REPORTED THAT STIMULATION WAS "INTERMITTENTLY TURNING ITSELF OFF." IT WAS NOTED THAT THIS OCCURRED "THROUGHOUT THE DAY, EVERY DAY." IT WAS STATED THAT IT WAS NOT POSITIONAL STIMULATION AND IMPEDANCE MEASUREMENTS WERE NORMAL. IT WAS NOTED THAT THE BATTERY COMPARTMENT OF THE PATIENT PROGRAMMER HAD SOME CORROSION, BUT IT WAS CLEANED OUT AND THE DEVICE WAS "WORKING FINE NOW." TWO DAYS LATER, IT WAS REPORTED THAT IMPEDANCE TEST RESULTS SHOWED NORMAL VALUES AND STIMULATION USE WAS "MOSTLY AT 24 HOURS A DAY WITH THE EXCEPTION OF A COUPLE RANDOM DAYS." IT WAS STATED THAT THE PATIENT WAS RE-EDUCATED ON HOW TO SYNC DEVICE WITH PROGRAMMER AND INSTRUCTED TO KEEP A DIARY. IT WAS NOTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93017 | 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 |