BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 4665650 · Received April 7, 2015

    Report

    Report Number
    6000032-2015-00062
    Event Type
    Malfunction
    Date Received
    April 7, 2015
    Report Date
    March 10, 2015
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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 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 7424, SERIAL # (B)(4), IMPLANTED: (B)(6) 1994, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3470, SERIAL # (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE RECEIVER. (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; #600 0032-2015-00060; #3004209178-2015-06110; #3004209178-2015-06111; #6000032-2015-00061].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229983 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1