BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2759054 · Received September 25, 2012

    Report

    Report Number
    3004209178-2012-08505
    Event Type
    Injury
    Date Received
    September 25, 2012
    Date of Event
    May 12, 2008
    Report Date
    May 21, 2008
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377845, LOT# V013079, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377845, LOT# V023008028, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4) IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED DUE TO AN OVER-DISCHARGED BATTERY. THE BATTERY OV ER-DISCHARGE WAS DISCOVERED DUE TO AN INABILITY TO PROGRAM. THE MANUFACTURER REPRESENTATIVE TRIED 3 OR 4 PHYSICIAN MODE RECHARGES, BUT IT DIDN'T WORK. AN X-RAY WAS CONDUCTED AND IT WAS DETERMINED THE BATTERY WAS NOT FLIPPED. THE PATIENT EXPERIENCED HIP PAIN. THE INS WAS HARD TO ACCESS AND TILTED IN THE POCKET. THE PATIENT'S COMPLIANCE WITH THE RECHARGING SCHEDULE WAS THE PRIMARY REASON FOR OVER-DISCHARGE. DUE TO THE PATIENT'S GIRTH, OBESE ABDOMEN, AND MENTAL INSTABILITY, RECHARGING WAS TOO DIFFICULT AND THE DOCTOR OPTED FOR A REPLACEMENT. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention