RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-06423
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Report Date
- March 26, 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
- CO, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).
(B)(4).
IT WAS REPORTED THE PATIENT'S POSITIONAL SETTINGS WERE LOST, AND THE STIMULATION DIDN'T CHANGE WITH THE PATIENT'S BODY MOVEMENT.
IT WAS REPORTED THAT WHEN THE PATIENT LAID DOWN AND ROLLED TO HIS RIGHT SIDE, WHERE THE DEVICE WAS IMPLANTED, HE FELT AN INCREASE IN STIMULATION AND A "SHOCKING" SENSATION. WHEN THE PATIENT SAT BACK UP, THE STIMULATION "WENT BACK TO NORMAL." IT WAS NOTED THAT THE PATIENT HAD THE DEVICE SET WHERE HE DID NOT ALWAYS FEEL STIMULATION. THE PATIENT COULD FEEL STIMULATION IN HIS LEGS WHEN HE MOVED A CERTAIN WAY OR LAUGHED, THAT WAS HOW THE PATIENT KNEW THE STIMULATION WAS WORKING. IT WAS DETERMINED THROUGH TROUBLESHOOTING THAT THE PATIENT'S ADAPTIVE STIM WAS TURNED OFF. THE PATIENT TURNED ADAPTIVE STIM ON AND WOULD TRY THE DIFFERENT POSITIONS AND WATCH TO SEE IF THE PROGRAMMER REGISTERED THE PATIENT'S POSITIONAL CHANGES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164496 | 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 | 00048 YR |