RESTORE
Report
- Report Number
- 3004209178-2013-07083
- Event Type
- Injury
- Date Received
- April 30, 2013
- Report Date
- April 18, 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
- MA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE RECHARGER; PRODUCT ID 377745, LOT# N0030362, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT# N0042225, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT# V042634, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT# V042634, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V042640, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V042640, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).
ADDITIONAL INFORMATION STATED THE PATIENT¿S PRIMARY DEVICE WAS THE FIRST ONE HE PUT IN AND IT DID ¿A LOT OF GOOD¿ AND WAS ¿PLACED PERFECTLY.¿ IT WAS NOTED THIS DEVICE COVERED THE WAIST DOWN, AND THE TWO PERIPHERAL STIMULATORS COVERED THE BACK. INFORMATION INDICATED THE BURNING SENSATION AND THE BACK THAT WAS ¿ RIDICULOUS NO MATTER WHAT¿ APPLY TO THE PATIENT'S PERIPHERAL NEUROSTIMULATORS. SEE MANUFACTURER REPORT # 3004209178-2013-07084 AND # 3004209178-2013-07085 FOR INFORMATION REPORTED PERTAINING TO THE PERIPHERAL NEUROSTIMULATORS.
IT WAS REPORTED THE PATIENT HAD A BURNING SENSATION WHEN THEY TURNED ON TWO OF THEIR PERIPHERAL IMPLANTABLE NEUROSTIMULATORS (INS). THE PATIENT REPORTEDLY HAD THOSE TWO DEVICES SET AT 6.0 VOLTS AND THEY WERE 'NOT DOING AS MUCH' BECAUSE THE PATIENT'S PAIN LOCATION WAS IN THE MIDDLE OF THEIR SPINE. THE PATIENT STATED THE 'ELECTRICITY IS JUST AS BAD AS THE PAIN.' IT WAS ALSO REPORTED THE PATIENT'S DEVICES HAD BEEN REPROGRAMMED EIGHT TIMES AND THE PATIENT STATED 'IT WAS AS GOOD AS IT GETS.' IT WAS ALSO REPORTED THE PATIENT HAD SPINAL STENOSIS FROM AN INJURY AT WORK AND HAD A SURGERY DONE THAT 'MESSED UP A DISC.' IT WAS NOTED THE PATIENT USED A SCOOTER OR WHEELCHAIR, OR CRUTCHES FOR SHORT DISTANCES. IT WAS ALSO STATED THE PATIENT HAD NUMBNESS DOWN THE BACK OF THEIR LEG, PAIN DOWN THE FRONT OF THEIR LEG AND THEIR BACK WAS 'RIDICULOUS NO MATTER WHAT THE DOCTORS DO OR PRESCRIBE.' THE PATIENT REPORTEDLY DID NOT USE T HE TWO DEVICES IN THE BACK DUE TO THE BURNING BUT HE DID USE THE 'MAIN' DEVICE AND IT WAS SET AT 10.5 VOLTS. ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN INDICATED THE PATIENT UNDERWENT 'REVISION' SURGERY DUE TO A 'LEAD BREAK.' A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IT WAS UNKNOWN AT THE TIME OF REPORT WHICH TWO OF THE PATIENT'S THREE IMPLANTED DEVICES WERE REFERENCED. BECAUSE OF THIS, A REPORT WAS FILED ON ALL THREE OF THE DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 187178 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |