RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-03463
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- February 5, 2013
- Report Date
- February 15, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID: 3998 LOT# V011610, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708340 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3708340 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).
FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR PHYSICIAN AND THE MANUFACTURER'S REPRESENTATIVE AND THAT THEIR CONCERNS WERE RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
IT WAS REPORTED THAT THE "WIRE WAS RECONNECTED" FOLLOWING MAJOR BACK SURGERY ON (B)(6) 2013 AND NOW THE PATIENT HAS FULL USE OF STIMULATION. IT WAS STATED THE PATIENT HAS AN APPOINTMENT WITH HER HEALTHCARE PROVIDER FOR (B)(6) 2013 AND WOULD LIKE THEIR REPRESENTATIVE PRESENT TO DO REPROGRAMMING FOLLOWING THE APPOINTMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97319 | 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 | 63 YR |