BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3240187 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12071
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 26, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 355029, LOT# N0043242, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3998, LOT# V002777, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CURRENTLY HAD TO GO TO A REHAB CLINIC WITH HER HUSBAND. IT WAS NOTED THAT "THEY" WERE TRYING TO HOOK UP A (B)(6) PHONE RECORDER AND IT WAS OBSERVED THAT THE RECORDING DEVICE TRIGGERED HER SYSTEM AND INTERFERED. IT WAS NOTED THAT THE REPORTER DID NOT KNOW WHAT PROBLEMS THIS CAUSED THE PATIENT BUT ¿IT DID.¿ IT WAS FURTHER NOTED THAT THIS OCCURRED 1-2 MONTHS AGO. THE REPORTER STATED THAT THEY DID NOT THINK THE PATIENT SHOULD BE IN "THIS" REHAB PLACE BECAUSE OF THE PROBLEMS THAT IT CAUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339627 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 00053 YR