BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3894071 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12019
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3776-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S STIMULATOR WAS BEING REPLACED DUE TO DEPLETION ON (B)(6) 2014. IT WAS NOTED THE PATIENT'S HIGH SETTINGS WERE THE CAUSE OF THE PREMATURE DEPLETION. IT WAS REPORTED THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WE'RE WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE.

    Description of Event or Problem · 1

    THE PATIENT¿S INS HAS NOT BEEN WORKING PROPERLY. THE PATIENT TRIED TO TURN IT UP BUT RECEIVED AND ERROR CODE ER0. THE PATIENT CHANGED THE BATTERY AND STILL RECEIVED THE ERROR CODE ER1. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371097 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1