BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3951116 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13382
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A COMMUNICATION PROBLEM. THE PATIENT RECHARGED ABOUT A WEEK PRIOR TO THE REPORT. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD NEVER BEEN IN THE BEST POSITION AND THE PATIENT HAD A HARD TIME FINDING THE SPOT. THE PATIENT USED ANTENNA LOCATE AND GOT A POWER ON RESET (POR) ON THEIR RECHARGER WHICH LED TO THE NORMAL RECHARGING SCREEN. THE PATIENT GOT 6 COUPLING BARS AND STARTED RECHARGING SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427962 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1