RESTORE ULTRA
Report
- Report Number
- 3004209178-2013-03642
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Report Date
- February 25, 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
- TN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).
THE CALLER REPORTS STIMULATION IN THE WRONG LOCATION. BEGAN OCCURRING ABOUT A WEEK AGO. CALLER REPORTS THAT SHE HAS PAIN IN HER LEG. CALLER REPORTS THAT LEFT INS IS IMPLANTED FOR HER LEGS AND THAT IT GETS STUCK ON HER BONE. PT REPORTS THAT SHE HAD A REVISION ABOUT 2 MONTHS AGO TO MOVE INS LOCATION, BUT IT IS STILL GIVING HER ISSUES. CALLER REPORTS THAT LAST NIGHT HER LEG PAIN WAS VERY BAD DESCRIBED AS RESTLESS LEG SYNDROME THAT WENT UP INTO HER ARM. CALLER WOULD LIKE TO SEE IF THE LEFT INS CAN BE RE-PROGRAMMED. CALLER REPORTS THAT HER LEAD ON THE RIGHT SIDE APPEARS TO BE GETTING CLOSER TO THE SURFACE IN THE MIDDLE OF YOUR BACK THIS IS CONCERNING TO HER DUE TO A PREVIOUS EXPERIENCE THAT SHE HAD WITH A WIRE THAT BECAME INFECTED AND ERODED THROUGH THE SKIN. WE HAVE MET WITH HER SEVERAL TIMES. WILL DO SO AGAIN. PATIENT INDICATED ¿NOT GETTING ADEQUATE COVERAGE ON HER LEFT SIDE.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER DOCTOR OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED NOTING AN APPOINTMENT DATE LAST MONTH. IT WAS NOTED THAT THE PATIENT HAD NUMBNESS, PAIN, AND ITCHING ON THE LEFT SIDE, AS WELL AS HAVING SOME PAIN THAT THE DEVICE DID NOT HELP WITH, BUT OVERALL THE PATIENT WAS GOOD.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER DOCTOR OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED NOTING AN APPOINTMENT DATE LAST MONTH. IT WAS NOTED THAT THE PATIENT HAD NUMBNESS, PAIN, AND ITCHING ON THE LEFT SIDE, AS WELL AS HAVING SOME PAIN THAT THE DEVICE DID NOT HELP WITH, BUT OVERALL THE PATIENT WAS GOOD.
IT WAS REPORTED THAT ABOUT A WEEK PRIOR THE REPORT THE PATIENT BEGAN RECEIVING STIMULATION IN THE WRONG LOCATION. THE PATIENT REPORTED THAT HER LEFT DEVICE WAS IMPLANTED FOR HER LEGS AND THAT "IT" GOT STUCK ON HER BONE. THE PATIENT REPORTED THAT SHE HAD PAIN IN HER LEG AND THE NIGHT BEFORE THE REPORT IT WAS VERY BAD AND WAS DESCRIBED AS RESTLESS LEG SYNDROME THAT WENT UP INTO HER ARM. THE PATIENT WANTED THE LEFT DEVICE REPROGRAMMED. THE PATIENT ALSO STATED THAT HER LEAD ON THE RIGHT SIDE APPEARED TO HAVE GOTTEN CLOSER TO THE SURFACE IN THE MIDDLE OF HER BACK AND THIS CONCERNED HER. LATER THAT DAY IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD MET THE PATIENT SEVERAL TIMES AND INTENDED TO DO SO AGAIN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105320 | 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 |