RESTORE ULTRA
Report
- Report Number
- 3004209178-2013-00852
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- January 3, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID 3888-56, LOT# V398029, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3888-56, LOT# V398029, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3487A-56, LOT# V396202, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3487A-56, LOT# V390366, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).
IT WAS REPORTED THE PATIENT SAW THEIR HEALTHCARE PROVIDER (HCP) DUE TO PROBLEMS WITH A DISK IN THEIR NECK. IT WAS STATED THAT THE HCP SAID THE DEVICE WAS "NOT EVEN CLOSE" TO WHERE THE PATIENT THOUGH IT WAS. IT WAS INDICATED THAT THE PATIENT HAD AN OCCIPITAL STIMULATOR AND THAT NONE OF THE LEADS WERE TOUCHING THE SPINAL CORD "WHERE THEY WERE SUPPOSED TO." THE PATIENT HAD "LEADS IN THE OCCIPITAL AREA, BUT NONE WERE TOUCHING THE COLUMN." IT WAS FURTHER STATED THE IMPLANT WAS "NOT PUT IN PROPERLY." DUE TO THE PLACEMENT, IT WAS INDICATED THE PATIENT "WOULD HAVE NEVER GOTTEN RELIEF." THE PATIENT HAD 13 TEETH REMOVED "UNNECESSARILY" AND WAS IN A "HEAD LOCK AND THE UNIT STARTED SHUTTING UP." IT WAS UNCLEAR WHAT WAS BEING ALLEGED IN THE PREVIOUS STATEMENT. IT WAS ORIGINALLY THOUGHT THAT THE LEADS HAD DISLODGED FROM THE SPINE WHEN THE PATIENT WAS GETTING TEETH REMOVED. IT WAS ALSO NOTED THAT THE DEVICE THAT WAS PLACED WAS NOT THE CORRECT DEVICE, SINCE "THIS DEVICE WAS FOR SPINAL CORD AND DOES NOT SAY OCCIPITAL." A LITTLE MORE THAN A WEEK LATER, IT WAS REPORTED NO SIGNAL COULD BE ACHIEVED FROM THE DEVICE. IT WAS STATED THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HIS DEVICE OR THERAPY BUT WAS WORKING WITH HIS HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. THE PATIENT WROTE ABOUT HIS FRUSTRATION WITH THE EVENT.
FOLLOW UP REPORTED, THE REPRESENTATIVE HAD NOT BEEN INFORMED OF ANY INTERVENTIONS TAKEN. FURTHER FOLLOW UP REPORTED, THE PATIENT'S FOLLOW UP HEALTH CARE PROFESSIONAL HAD NOT SEEN THE PATIENT SINCE (B)(6) 2012. THEY HAD NO INFORMATION ON THE EVENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STIMULATOR BROKE ABOUT 4.5 YEARS AGO. THE WIRES IN THE PERIPHERAL NERVES IN HIS NECK BROKE. THE STIMULATOR AND THE WIRES WERE EXPLANTED ON (B)(6) 2014. HE HAD AN 8 INCH INCISION TO HAVE THE WIRES EXPLANTED AND THE BROKEN WIRES WERE DIFFICULT TO EXPLANT. IT WAS NOTED THAT HE NEEDED AN MRI TO HAVE A LUMP ON HIS NECK TAKEN OFF. THE LUMP AND MRI WERE NOT RELATED TO THE DEVICE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29450 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |