BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 6064136 · Received October 28, 2016

    Report

    Report Number
    3004209178-2016-22798
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Report Date
    January 24, 2017
    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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR CHRONIC LOW BACK PAIN. IT WAS REPORTED THAT THERE WAS POOR COMMUNICATION ON THE PATIENT PROGRAMMER. THE PATIENT HAD A NON-RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS) AND HAD NOT HAD ANY RECENT SURGERIES. THE PATIENT DID NOT TYPICALLY USE THE ANTENNA. THE PATIENT WAS IMPLANTED ON (B)(6) 2010 AND STATED THAT THEY HAD NEVER HAD THE INS BATTERY TESTED. THEY DID NOT CURRENTLY HAVE A MANAGING HEALTH CARE PROFESSIONAL (HCP). HCP LISTINGS WERE REQUESTED AND SENT. THE ¿STIMULATOR WENT OUT OF WACK.¿ THEY HAD NOT USED STIMULATION BECAUSE THEY HAD NOT NEEDED TO. THEY DID NOT KNOW HOW LONG THE INS HAD BEEN OFF. THE PATIENT TRIED TO TURN THEIR STIMULATION ON A COUPLE OF DAYS AGO IN (B)(6) 2016 BUT ONLY SAW THE POOR COMMUNICATION SCREEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT THAT REPORTED THAT THE PATIENT COULD NOT CONNECT WITH THE IMPLANTABLE NEUROSTIMULATOR. THE PATIENT WAS LOOKING TO SCHEDULE AN APPOINTMENT WITH A HEALTH CARE PROVIDER; HOWEVER DID NOT HAVE ONE AT THE TIME THAT THE ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT INQUIRED ABOUT THE NEXT STEPS IF THE IMPLANTABLE NEUROSTIMULATOR BATTERY WAS DEPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714114 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1