BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3229885 · Received July 16, 2013

    Report

    Report Number
    3007566237-2013-02361
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS NOT SURE WHY HE HAD HIS PUMP REPLACED. IT WAS REPORTED THAT THE PHYSICIAN INFORMED THE PATIENT IT WAS RELATED TO ¿A BATTERY ISSUE,¿ BUT THE PATIENT VOICED CONCERN THE PHYSICIAN WAS WITHHOLDING INFORMATION. THE PATIENT INDICATED HE WAS NOT ¿PRIVY TO THE ALARM SEQUENCE TO WHY THE PUMP HAD TO BE CHANGED IN THE FIRST PLACE.¿ THE PATIENT STATED, ¿ I DON¿T KNOW IF IT WAS BECAUSE THE PUMP WAS LEAKING. I¿M NOT PRIVY TO THAT INFORMATION BUT, YOU KNOW, I¿VE HAD HEADACHES GOING ON FOR SOME YEARS BACK.¿ THE PATIENT STATED, ¿I¿M A PARAPLEGIC SO I DON¿T REALLY THINK I MADE A GOOD PATIENT AS FAR AS IN THIS PUMP.¿ THE PATIENT STATED, ¿THERE WAS MAYBE ISSUES WITH THE FIRST PUMP THAT I DIDN¿T KNOW ABOUT.¿ THE PATIENT REPORTEDLY FOUND INFORMATION ABOUT PUMP RECALLS AND WAS QUESTIONING IF HIS PUMP WAS ON THIS RECALL LIST. THE PATIENT STATED HE HAS HAD MRIS AND AND CAT SCANS IN THE PAST, AND ¿NOT ONCE HAS HE TOLD ME THAT THIS PUMP HAD TO BE TURNED OFF.¿ HE WENT ON TO SAY, ¿ALL I¿M JUST SAYING IS THAT A LOT OF INFORMATION WASN¿T GIVEN TO ME.¿ THE PUMP WAS USED TO DELIVER CLONIDINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328277 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention