BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2191793 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05698
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NEVER EXPERIENCED THERAPEUTIC EFFECT SINCE THE PUMP WAS IMPLANTED. A VOLUME DISCREPANCY AT THE INITIAL PUMP REFILL WAS NOTED: THE ACTUAL RESIDUAL VOLUME WAS 40 MLS. THE EXPECTED VOLUME WAS 4 MLS. AN ALARM WAS HEARD BUT NOT CONFIRMED BY TELEMETRY. PER THE REPORTER, THE HCP REMOVED THE DRUG AND TURNED THE PUMP OFF. THE PT UNDERWENT A CATHETER DYE STUDY ON (B)(6) 2011. FOLLOWING THE DYE STUDY, THE PT EXPERIENCED AN INFECTION. PER THE REPORTER, THE INFECTION WAS NOT RELATED TO THE PUMP. DURING THE CATHETER STUDY, THE HCP INDICATED THERE WAS AN AREA WITH A POSSIBLE KINK. THERE WAS A PLAN TO REPLACE THE CATHETER ON (B)(6) 2011. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL. ADD'L INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731SC, LOT # N242142001