BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3840526 · Received May 30, 2014

    Report

    Report Number
    3007566237-2014-01484
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3625, IMPLANTED: 2014-(B)(6), PRODUCT TYPE SCREENING DEVICE. PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD, PRODUCT ID NEU_PTM_PROG, PRODUCT TYPE PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    (B)(6) 2014: IT WAS REPORTED THAT THE PATIENT HAD A TRIAL STIMULATION SYSTEM PLACED ON 2014-(B)(6). IT WAS STATED THAT THE PATIENT HAD FIRST THOUGHT THAT THERE WAS A REPROGRAMMING ISSUE, BECAUSE ¿IT¿S NOT WORKING,¿ BUT LATER THAT MORNING THE PATIENT¿S DRESSING CAME OFF AND IT WAS THOUGHT THAT THE LEADS HAD GOTTEN ¿TUGGED ON¿ AND WERE NO LONGER IN THE CORRECT POSITION. IT WAS FURTHER STATED THAT ¿IT¿S REALLY UNCOMFORTABLE¿ AND THE PATIENT HAD A HEADACHE. IT WAS NOTED THAT THE PATIENT WAS GOING TO HAVE THE SYSTEM TAKEN OUT ON THE MONDAY FOLLOWING THIS REPORT. IT WAS FURTHER NOTED THAT THE PATIENT WAS WORRIED THAT THE IMPLANT SITE WOULD GET INFECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD GREATER THAN FIFTY PERCENT SYMPTOM REDUCTION WITH THE TRIAL. THE PATIENT WAS GOING TO SCHEDULE APPOINTMENT TO DISCUSS PERMANENT IMPLANT. THE PATIENT'S SYMPTOMS WERE STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319496 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention