RESTORE SENSOR
Report
- Report Number
- 3004209178-2012-11300
- Event Type
- Malfunction
- Date Received
- December 10, 2012
- Report Date
- November 9, 2012
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS RECEIVING STIMULATION IN THE WRONG LOCATION. DESPITE "GOOD" IMPEDANCES, ALL <(><<)>1,000 OHMS EXCEPT 8 AND 9 WERE >10,000 OHMS, THE ONLY PLACE THE PATIENT FELT STIMULATION WAS AT THE POCKET SITE AT AMPLITUDES GREATER THAN FOUR VOLTS. THIS ISSUE BEGAN WITH THE PREVIOUS DEVICE AND CONTINUED WITH THIS NEW DEVICE. THE PATIENT REPORTED NO FALLS. IT WAS BELIEVED THAT THE LEADS MAY HAVE MIGRATED AND THE ELECTRODES WERE CLOSE OR IN THE POCKET SITE, LEADING TO THE STIMULATION IN THE WRONG LOCATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. PLEASE SEE MANUFACTURING REPORT #3004209178-2012-11187 FOR RELATED EVENT. THE PATIENT'S PREVIOUS DEVICE HAD THE SAME STIMULATION ISSUE AND HAD FLIPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 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 |