BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTREL

    MDR report key: 4665664 · Received April 7, 2015

    Report

    Report Number
    3007566237-2015-00920
    Event Type
    Malfunction
    Date Received
    April 7, 2015
    Report Date
    March 10, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7425, SERIAL# (B)(4), IMPLANTED: (B)(6) 1997, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7425, SERIAL# (B)(4), IMPLANTED: (B)(6)1999, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7427, SERIAL# (B)(4), IMPLANTED: (B)(6), 2004, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37702, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7427, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7424, SERIAL# (B)(4), IMPLANTED: (B)(6) 1994, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ELECTROMAGNETIC INTERFERENCE IN THE PAST. THEY HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) SINCE 1994. WHEN THE PATIENT WOULD GO INTO STORES THROUGH THE THEFT DETECTORS, THEIR DEVICE WOULD TURN ON AND GO UP. WHEN THEY WERE TEACHING AT AN ELEMENTARY SCHOOL AND THE MAIN FRAME WENT DOWN, THEIR DEVICE TURNED OFF. IT WAS WITH THE PATIENT¿S LEGACY DEVICES. INFORMATION REGARDING FURTHER INFORMATION ABOUT THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. [IT WAS UNKNOWN WHICH INS(S) HAD THESE ISSUES. SEE PATIENT¿S OTHER DEVICES, REFERENCE MANUFACTURING REPORT #6000032-2015-00059; #6000032-2015-00060; #3004209178-2015-06110; #3004209178-2015-06111; #6000032-2015-00061; #6000032-2015-00062].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230028 XTREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 3470

    Patients

    Seq Age Sex Outcome Treatment
    1