BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4193039 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20172
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 2, 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

    PRODUCT ID 74001, LOT# N248275, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: 1998 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3888-45, LOT# L46455, IMPLANTED: 1998 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NO LONGER EFFECTIVE AND WORKING LIKE IT SHOULD AND THE PATIENT WAS HAVING ISSUES WHERE THE INS WAS. THE PATIENT WAS TOLD THAT SOME PARTS OF WHERE IT HOOKED UP WERE BROKEN AND WERE ABLE TO HOOK UP THE REPLACEMENT. THE PATIENT¿S OLD HEALTHCARE PROVIDER (HCP) CHANGED THE BATTERY IN 2011, WHICH WAS THE PATIENT'S LAST SURGERY THEY HAD, AND WANTED TO FOLLOW UP WITH THAT HCP TO SEE IF HE MIGHT BE ABLE TO EXPLANT THE DEVICE PER THE PATIENT¿S REQUEST. THE PATIENT HAD NOT GONE THROUGH ANY REPROGRAMMING. THERAPY STOPPED FOR THE PATIENT OVER TWO YEARS AGO AT THE TIME OF THE REPORT AND IT HAD REALLY GIVEN THE PATIENT PROBLEMS WHERE IT WAS AT, AND ALSO WHERE IT WAS FUSED INTO THE PATIENT¿S UPPER BACK. A LITTLE OVER TWO YEARS AGO THE INS LOCATION ISSUE STARTED, AND THE PAIN FROM THE LOCATION OF THE INS WAS MORE FREQUENT WHERE AS BEFORE IT WAS OFF AND ON AND THE PATIENT DIDN¿T KNOW WHAT WAS GOING ON WITH IT SINCE THEY MENTIONED PARTS WERE BROKEN AND THEY CONNECTED ANYHOW. THE PATIENT WANTED TO HAVE IT REMOVED AND OTHER OPTIONS. THE PATIENT SYMPTOMS WERE A GRADUALLY PROGRESSING AND THEN IT HAD GOTTEN A LOT WORSE. THERE WERE NO FALLS OR TRAUMAS TO WHERE SHE LANDED WHERE THE IMPLANT WAS. SHE HAD FALLEN BACKWARD ON HER BACK BUT DIDN¿T FALL WHERE THE INS BATTERY WAS ITSELF. THE FALL ON HER BACK WAS FIVE YEARS AGO PRIOR TO THE REPORT AND SHE FELL OUTSIDE. INFORMATION REGARDING IF THE PATIENT STILL HAD CONCERNS ABOUT THEIR DEVICE OR THERAPY HAS BEEN REQUESTED WHICH WAS NOT REPORTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671506 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 00051 YR