BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3843088 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09948
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 14, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT# V034832, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID A01411002, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE PATIENT HAD DIFFICULTY FOR THE PAST MONTH CHARGING THE DEVICE. THE PATIENT HAD A HARD TIME USING THE BELT, AND THE BELT CAUSED ITCHING. TO GET GOOD COUPLING BARS, THE PATIENT USES A PANTY OR HOLDS IT IN PLACE USING HER HAND. THE PATIENT REPORTEDLY WOULD GET ALL COUPLING BARS, THEN GRADUALLY DECREASED, AND THEN NO COUPLING BARS. NO FALLS OR TRAUMA REPORTED. THE PATIENT FELT LIKE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SPLITTING IN HALF, AND ¿FELT LIKE IT WAS BROKEN.¿ THE PATIENT REPORTEDLY FELT THE SHOCKING SENSATION DURING CHARGING WHEN THE COUPLING BARS DISAPPEARED, BUT NOT WHEN THEY WERE PRESENT. THE PATIENT HAD AN OFFICE VISIT WITH THE HEALTH CARE PROVIDER SCHEDULED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322279 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 00071 YR