BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3951241 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13391
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    July 1, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY IN THE PATIENT¿S STIMULATOR FAILED AFTER ONLY 18 MONTHS. A MANUFACTURER REPRESENTATIVE TOLD THE PATIENT THAT IT FAILED EARLY BECAUSE THEY WERE USING IT TOO HIGH. THE REPRESENTATIVE ALSO QUESTIONED SOME OF THE SETTINGS THAT WERE SET UP. THE PATIENT HAD THEIR BATTERY REPLACED AND IT WAS WORKING WELL AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427797 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention