BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3191466 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10941
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-29, LOT# N142740, IMPLANTED: 2009-(B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 399960, LOT# V015233, IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S STIMULATOR DISPLAYED THE EARLY REPLACEMENT INDICATOR (ERI). THEPATIENT WAS SCHEDULED FOR REPLACEMENT FOR THE FOLLOWING DAY. IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES ON ALL CONTACTS WITH 0 AND 3, GREATER THAN 40,000 OHMS. THE PHYSICIAN DID NOT PLAN TO CHANGE THE LEAD AND PLANNED INSTEAD TO REPROGRAM AROUND THE OPEN CIRCUIT. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE BATTERY DEPLETION WAS CONSIDERED NORMAL. IT WAS NOTED THAT A COUPLE OF ELECTRODE IMPEDANCES REMAINED OUT OF RANGE. THE MANUFACTURING REPRESENTATIVE WAS REPORTEDLY ABLE TO CAPTURE THE PATIENT¿S PAINFUL AREAS BY REPROGRAMMING AROUND THE AFFECTED ELECTRODES. IT WAS NOTED THAT THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291465 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR