BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3811418 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08996
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-39, LOT # N328292, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 3550-29, LOT # N288896, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TAKEN SEVERAL FALLS AND WAS NOT SURE THAT THEIR DEVICE WAS WORKING CORRECTLY ANYMORE. THE PATIENT HAD FALLEN AT LEAST 5-6 TIMES AND STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING. THE PATIENT WAS UNSURE IF THE INS WAS NOT WORKING OR IF THEY JUST COULDN¿T TELL. THE PATIENT NOTICED THE ISSUES OVER THE 4-5 MONTHS PRIOR TO THE REPORT. THE INS WAS NOT THE SAME SIZE AND SHAPE AS IT WAS BEFORE THE FALLS. 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
    291988 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1