BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3728529 · Received April 7, 2014

    Report

    Report Number
    3004209178-2014-05679
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Report Date
    March 13, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3887-33, LOT# V014071, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3887-33, LOT# J0540948V, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# V009632, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# V015619, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD, PRODUCT ID: 3887-33, LOT# V014071, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3887-33, LOT# J0540948V, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# V009632, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# V015619, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING SOME PROBLEMS WITH THE IMPLANT. IT WAS NOTED THAT THE PATIENT THOUGHT THAT "HALF OF THE LEAD WIRES STOPPED WORKING." IT WAS REPORTED THAT THE PATIENT NEEDED A KNOWLEDGEABLE DOCTOR WHO COULD "FIX WHAT DR. (B)(6) DID WRONG." IT WAS NOTED THAT THE PATIENT'S IMPLANT SURGERY WAS VERY PAINFUL AND OVER 5 1/2 HOURS LONG. IT WAS NOTED THAT THE DOCTOR "STILL DID NOT GET THE LEADS IN THE NECK CORRECTLY, AND THE LOWER BACK LEADS DID NOT SEEM TO BE WORKING" AT THE TIME OF REPORT. IT WAS NOTED THAT THE BATTERY USED "VERY LITTLE JUICE" AND THE PAIN WAS BACK. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207191 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1