BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3162755 · Received June 11, 2013

    Report

    Report Number
    3007566237-2013-01930
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THEY WENT IN TO DO A ROUTINE PUMP REPLACEMENT, THEY FOUND THAT THE CATHETER WAS COMPROMISED; IT WAS BROKEN, SO THE PUMP AND CATHETER WERE REPLACED. THE PATIENT NEVER GOT SICK AND NEVER HAD WITHDRAWALS PRIOR TO THE DISCOVERY, SO IT WAS ASSUMED THAT SHE WAS GETTING SOME AMOUNT OF MEDICATION. THE DOSE FOR THE NEW PUMP WAS DECREASED BY 50% OF WHAT IT HAD BEEN. FOLLOWING THE REPLACEMENT, THE PATIENT SPENT THE NIGHT IN THE HOSPITAL. THE PUMP WAS DELIVERING DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262399 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR