BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2387928 · Received December 23, 2011

    Report

    Report Number
    3004209178-2011-10045
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Report Date
    December 6, 2011
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROGRAMMER: MODEL 37743, SERIAL# (B)(4), ACCESSORY: MODEL 37752, SERIAL# (B)(4), ANCHOR: MODEL 3550-39, LOT# N267543, IMPLANTED: (B)(6) 2011, EXPLANTED: NA, LEAD: MODEL 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA, ACCESSORY: MODEL 3550-29, LOT# N260112.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "STABBING PAIN" IN HER BACK AND COLDNESS OVER THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE, BEGINNING IN THE MIDDLE OF (B)(6) 2011. THE SYMPTOMS WERE ALSO PRESENT WHEN THE DEVICE WAS TURNED OFF. THE PATIENT COULD NOT ADJUST STIMULATION, AND IT APPEARED THAT THE PROGRAMMER'S ALKALINE BATTERIES NEEDED TO BE REPLACED. THE PATIENT ALSO EXPERIENCED A BURNING FEELING AROUND THE DEVICE WHEN THE WEATHER TURNED COLD. IT WAS LATER REPORTED THAT THE PATIENT HAD SUFFERED A FALL IN SEPTEMBER THAT AGGRAVATED THE BACK INJURY. THE PATIENT WAS TAKING VICODIN TO HELP WITH THE PAIN, AND HAD LOST WEIGHT SINCE THE INS IMPLANT, GOING FROM (B)(6). IT WAS NOTED THAT THE INS WAS HELPING WITH THE LEG PAIN THAT IT WAS IMPLANTED FOR. IT WAS ALSO REPORTED THAT THE PATIENT HAD EXPERIENCED "SEVERE SHOCKS" AT THE INS SITE WHILE RECHARGING. THE PATIENT HAD AN APPOINTMENT WITH HER HCP SCHEDULED FOR (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SHOWED THE PATIENT WAS SEEN BY THEIR HCP AND A MANUFACTURER REPRESENTATIVE. THE DEVICE WAS INTERROGATED, AND IMPEDANCES ON ELECTRODE 5 WERE >10,000 OHMS. THE PROGRAM THE PATIENT WAS USING DID NOT UTILIZE THIS ELECTRODE. SHE WAS RECEIVING GOOD PARASTHESIA FROM THE DEVICE. THE "SHOCKING AND JOLTING" THAT THE PATIENT HAD REPORTED WAS FOUND TO BE DUE TO STIMULATION CHANGES RELATED TO POSITIONAL CHANGES, AND THE PATIENT WAS SUCCESSFULLY RE-EDUCATED ON HOW TO USE THE PATIENT PROGRAMMER TO ADJUST FOR POSITIONAL CHANGES. THE PATIENT PROGRAMMER AND RECHARGER WERE WORKING APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1