BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4110205 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17535
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHORTLY AFTER IMPLANT THERE WAS A LIGHTNING AND THUNDER STORM THAT MADE THE PATIENT¿S SYSTEM GO ¿OUT OF WHACK.¿ THE PATIENT DESCRIBED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WENT ¿WHACKO¿ AND WAS DEPROGRAMMED. THIS OCCURRED SOME MONTHS AFTER IMPLANT AND THE PATIENT DID NOT REMEMBER EXACTLY WHEN. THE PATIENT DID CLARIFY THAT THE INS GOING ¿WHACKO¿ MEANT THAT THEY WERE GETTING A NO TELEMETRY MESSAGE ON THEIR PATIENT PROGRAMMER. THE PATIENT HAD WORKED WITH A MANUFACTURING REPRESENTATIVE TO RECONNECT WITH THE INS AND THE ISSUE WAS RESOLVED. THE PATIENT HAD NOT SEEN A POWER ON RESET MESSAGE ON THE PATIENT PROGRAMMER DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589580 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR