BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3790132 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08498
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 10, 2014
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED NO STIMULATION SENSATION. A FEW YEARS BACK THE PATIENT HAD A ¿CERVICAL ELECTRONIC STIMULATOR¿ IMPLANTED. THE LAST FEW DAYS THE PATIENT¿S ¿UNIT¿ STOPPED WORKING. THE PATIENT PROGRAMMER¿S (PP) BATTERIES WERE REPLACED BUT IT STILL WAS NOT MAKING A CONNECTION BETWEEN THE PP AND INS. APPARENTLY THE PATIENT WAS NOT GETTING ANY STIMULATION. THE REPORTER WAS GETTING ALL THE INFORMATION THIRD HAND AND WAS UNSURE OF WHAT EXACTLY WAS GOING ON. THE PATIENT WAS CURRENTLY AT HER HEALTH CARE PROVIDER¿S (HCP) OFFICE. IT WAS NOTED THAT THE PATIENT WAS GOING THROUGH DEMENTIA. IT WAS HARD TO TELL HOW LONG THE PATIENT HAS HAD PROBLEMS WITH THE PP SINCE SHE HAS DEMENTIA, SOMETIMES SHE REMEMBERS AND SOMETIMES SHE FORGETS. THREE DAYS AGO THE PATIENT¿S BACK HAD BEEN BOTHERING HER AND WHEN ASKED IF SHE HAD BEEN USING HER INS, SHE STATED ¿OH, UMM, NO, I DON¿T KNOW WHERE IT¿S AT¿. IT TOOK 3 DAYS TO FIND THE PP AND THE BATTERIES WERE DEAD, SO THEY WERE CHANGED BUT IT DID NOT FIX THE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267066 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1