BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2191769 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05696
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PUMP HAD FLIPPED. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS HYDROMORPHONE. 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 PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR IMPLANTED:| CATHETER: MODEL 8731SC, LOT # N272493015| EXPLANTED: