BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3139305 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08433
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3093-33 LOT# V963187, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3093-33 LOT# V909187, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HURT HER BACK ON (B)(6) AT WORK. THE PATIENT DIDN'T FEEL LIKE THE DEVICE WORKED AT ALL ANYMORE. AFTER THE FALL, TOWARDS THE (B)(6), WAS WHEN THE PATIENT FELT LIKE THE DEVICE STOPPED WORKING. THE PATIENT HAD TRIED ADJUSTING IT BUT IF SHE TURNS IT UP IT IS TOO HIGH AND HURTS, IF SHE TURNS IT DOWN IT IS NOT STRONG ENOUGH AND DOESN'T WORK. THE PATIENT HAD TRIED INJECTIONS AND PHYSICAL THERAPY FOR HER BACK AND THEY WERE NOT WORKING. THEY HAD DONE A CT SCAN. THE PATIENT HADN'T SEEN THEIR PHYSICIAN REGARDING HER DEVICE DUE TO INSURANCE REASONS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240970 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR