RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-01056
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Report Date
- January 7, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 3986A60 LOT# N280985, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3888-56 LOT# V920378, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3888-56 LOT# V472483, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708360 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3708360 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).
IT WAS REPORTED THAT WHEN A PATIENT MOVED HIS HEAD A CERTAIN WAY "THE DEVICE WENT CRAZY." THE PATIENT WAS IMPLANTED TO TREAT MIGRAINES. IT WAS STATED THAT THE DEVICE ISSUES HAD STARTED A WEEK AGO. A DAY LATER, A SHOCKING OR JOLTING SENSATION WAS REPORTED. IT WAS STATED THAT WHEN THE PATIENT TURNED HIS HEAD HE RECEIVED "SURGING OF ENERGY." ONE DAY AGO, THE PATIENT WAS DIRECTED BY HIS HEALTHCARE PROFESSIONAL (HCP) TO TURN THE STIMULATION OFF. IT WAS ALSO STATED THAT AN APPOINTMENT WAS RESCHEDULED TO (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37922 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO | 37714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |