BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3983875 · Received August 6, 2014

    Report

    Report Number
    3007566237-2014-02199
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 18, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A PROBLEM WITH HER PATIENT PROGRAMMER. THE PATIENT REPORTEDLY OBSERVED A POOR COMMUNICATION SCREEN WHEN ATTEMPTING TO CONNECT TO HER IMPLANTABLE NEUROSTIMULATOR (INS). FOR THE FOURTEEN DAYS PRIOR TO REPORT, THE PATIENT¿S PROGRAMMER HAD BEEN UNABLE TO COMMUNICATE WITH HER INS. AFTER REPLACING THE PROGRAMMER¿S BATTERIES HOWEVER, ¿IT RETURNED TO WORK PERFECTLY.¿ THERE WERE NO PATIENT INJURIES REPORTED DUE TO THE EVENT. ADDITIONAL INFORMATION STATED THE CAUSE OF THE EVENT WAS THAT THE PROGRAMMER ¿JUST NEEDED TO CHANGE BATTERIES.¿ THE PATIENT WAS REPORTED TO HAVE BEEN ¿RECEIVING EFFECTIVE THERAPY NORMALLY¿ AS OF TWO DAYS AFTER INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT LIVED 100 METERS FROM A CELL SITE AND THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FREQUENTLY TURNED OFF. THE PATIENT WAS ABLE TO TURN THE INS ON WITH PATIENT PROGRAMMER. NO INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED REGARD THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459399 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1