BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3081392 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06976
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 15, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37754, SERIAL #(B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39286-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED COUPLING ISSUES AND WAS ONLY ABLE TO GET 2 "BLACK BARS" WHEN RECHARGING. TWO DIFFERENT RECHARGERS WERE USED TO ATTEMPT TO RECHARGE THE BATTERY, BUT THEY COULD ONLY GET 2 BLACK BARS "AT BEST" FOR COUPLING. THE ANTENNA LOCATE FEATURE WAS ATTEMPTED AND ONLY A "52" WAS OBTAINED IN "BEST LOCATION." NO PATIENT SYMPTOMS OR INJURY WAS REPORTED. THE PATIENT WOULD BE MEETING WITH THE SURGEON TO DISCUSS REPOSITIONING THE BATTERY. SIX WEEKS LATER IT WAS REPORTED THAT PATIENT'S BATTERY WAS RE-POSITIONED TO IMPROVE RECHARGING. IT WAS STATED THAT THE PATIENT WAS GETTING GOOD STIMULATION COVERAGE, IT WAS HELPING HIS PAIN, AND THE PATIENT WAS ABLE TO RECHARGE EASIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182351 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention