BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2875183 · Received December 17, 2012

    Report

    Report Number
    3004209178-2012-11888
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 24, 2012
    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 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

    IT WAS REPORTED THE PATIENT EXPERIENCED A "SHOCKING" SENSATION WHEN SHE SAT DOWN THAT TRAVELLED UP HER SPINE AND INTO HER HEAD, WHICH GAVE HER A HEADACHE. THE BATTERY WAS ON CYCLING MODE AND IT CUT OFF RIGHT WHEN THE PATIENT SAT DOWN; IT KICKED BACK ON AS USUAL AND THE EVENT DID NOT HAPPEN AGAIN. NO ACTION WAS REQUIRED BECAUSE THE PATIENT GOT GREAT COVERAGE AND HAD NOT REPORTED THE EVENT AGAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR