BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 6055321 · Received October 25, 2016

    Report

    Report Number
    3004209178-2016-22508
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 25, 2016
    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 MEDICAL PRODUCTS: PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A CONSUMER IMPLANTED FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME REPORTED THE RECHARGER WASN¿T WORKING BECAUSE IT WOULDN¿T CHARGE, AND THEY ONLY HAD HALF OF THE CHARGE. ON (B)(6) 2016 THE CONSUMER CALLED BACK AND STATED THEY WERE SHAKING BECAUSE THEY WERE TIRED AND DIDN¿T HAVE THE CHARGE. TROUBLESHOOTING WAS PERFORMED ON THE PHONE WHICH RESULTED IN THE CONSUMER BEING ABLE TO GET FULL COUPLING BARS, AND THE RECHARGER MAKING A ¿CLICKING SOUND.¿ THE HEALTHCARE PROVIDER (HCP) LATER REPORTED THE CAUSE OF THE RECHARGER NOT WORKING WAS DUE TO THE DEVICE BEING LEFT IN A HOT CAR AND EXPOSED TO DIRECT SUNLIGHT. AFTER THIS THE RECHARGER WAS PLACED IN A COOL ENVIRONMENT, POWERED OFF, AND POWERED BACK ON, AND RESUMED ITS¿ NORMAL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706903 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 56 YR