BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2990005 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03324
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748966, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: EXTENSION: PRODUCT ID 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3888-33, LOT# J0322009V, IMPLANTED: (B)(6) 2003. PRODUCT TYPE: LEAD. (B)(4). THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS HEADACHES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE "ZAPPED HER REALLY GOOD" AFTER HITTING HER HEAD ON THE WINDOW IN A CAR ACCIDENT ON (B)(6) 2013. IT WAS STATED THAT THE DEVICE "MISFIRED ABOUT FOUR TIMES." IT WAS ALSO STATED THAT HER "KNEE WOULDN'T HOLD HER UP AND SHE COULDN'T PUT ANY WEIGHT ON IT." THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93811 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR