BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1213788 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-06760
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    March 27, 2008
    Report Date
    January 24, 2017
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) APPLIES TO THE LEAD THAT WAS REPORTED TO BE DISPLACED/MOVED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING REPLACEMENT OF THE PT'S STIMULATOR, THE PT EXPERIENCED A LACK OF PAIN RELIEF COVERAGE IN THE BACK OR LEGS. INSTEAD, THE PT EXPERIENCED SHOCKING IN THE ABDOMEN. THE LEADS HAD BEEN IN PLACE SINCE 1998. THE PT DID NOT FEEL THE LEADS HAD CHANGED POSITIONS. THE PT'S OLD SPINAL CORD STIMULATOR WAS REPLACED. THE LEADS WERE NOT TESTED INTRAOPERATIVELY. THE NEW STIMULATOR WAS PLACED. IN RECOVERY, THE NEW DEVICE WAS BEING PROGRAMMED. IT ONLY PROVIDED STIMULATION IN THE LEFT KNEE AND LOWER THIGH. TURNING UP THE VOLTAGE PRODUCED A SHOCKING SENSATION IN THE ABDOMEN. WHILE IN THE RECOVERY ROOM, THE PT HAD REPORTED THE NEW DEVICE WAS NOT WORKING PROPERLY. IT WAS FELT THE DEVICE NEEDED TO BE REPROGRAMMED. THAT NIGHT REPROGRAMMING WAS ATTEMPTED BUT AGAIN THE PT FELT SHOCKS IN THE ABDOMEN. THE FOLLOWING DAY TROUBLESHOOTING WAS ATTEMPTED, BUT A SUITABLE PROGRAM WAS NOT FOUND. A FEW DAYS LATER, THE PT WAS SEEN IN THE CLINIC. AGAIN, PROGRAMMING WAS ATTEMPTED WITHOUT SUCCESS. A MALFUNCTION WAS SUSPECTED. THE PHYSICIAN FELT THE LEADS HAD MOVED. THE PHYSICIAN SUGGESTED RETURNING TO THE OPERATING ROOM TO REPLACE THE LEADS AND/OR THE ENTIRE SYSTEM. FOLLOWING THE INITIAL REPLACEMENT SURGERY, THE PT HAD A SEVERE EPISODE OF THEIR FIBROMYALGIA MAKING IT IMPOSSIBLE TO UNDERGO ANOTHER SURGERY. THE PT WAS EXPERIENCING NAUSEA AND ACHING THROUGHOUT THEIR BODY. THE PHYSICIAN ORDERED A TENS UNIT FOR THE PT TO USE FOR PAIN RELIEF IN THE INTERIM, WHICH HAD LITTLE EFFECT ON THE PT'S PAIN RELIEF. IT WAS UNCLEAR IF THE LACK OF PAIN RELIEF WAS DUE TO A LEAD DISPLACEMENT ISSUE OR IF THERE WAS A COMPATIBILITY ISSUE WITH THE PT'S OLD LEADS AND THE NEW TYPE OF STIMULATOR. THE DEVICE REMAINS IMPLANTED AS THE PT IS UNABLE TO UNDERGO SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT MENTIONED ISSUES THAT WERE UNRELATED TO THE DEVICE AND OCCURRED PRIOR TO THE IMPLANTED DEVICE. THE PATIENT ALSO STATED THAT THEIR INS WAS DEACTIVATED BY THE DOCTOR'S OFFICE WITHIN A WEEK BECAUSE IT WAS NEVER WORKING RIGHT. HOWEVER, THE DOCTOR'S OFFICE REPORTED THEY HAD NOT DEACTIVATED THE PATIENT'S DEVICE, AND THE PATIENT MUST HAVE TURNED IT OFF THEMSELVES. THE PATIENT SAID IT WAS NOT WORKING RIGHT IN RECOVERY AND THE PATIENT WAS TOLD TO GO HOME AND WATCH THE VIDEO. THE PATIENT TRIED TO ADJUST IT AND ELECTROCUTED DOWN THEIR LEG. THE PATIENT WAS SUPPOSED TO SCHEDULE A LEAD REVISION BECAUSE THE LEADS HAD MOVED BUT HAD NEVER SCHEDULED IT BUT RATHER HAD TRIED REACHING OUT TO THE MANUFACTURER REPRESENTATIVES. THE PATIENT SAID THEY MET WITH A MANUFACTURER'S REPRESENTATIVE (REP) AND THE DOCTOR, AND THE DOCTOR WANTED TO REMOVE THE ENTIRE SYSTEM. THE PATIENT SAID THEY JUST WANTED THE BATTERY CHANGED BUT THAT WAS NOT AN OPTION, SO THE DEVICE WAS DEACTIVATED. THE DOCTOR'S OFFICE STATED THAT THE PATIENT HAD NOT BEEN IN SINCE (B)(6) OF 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention EXPLANTED:| EXTENSION: MODEL 37083| ACCESSORY: MODEL 37752| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743