BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1150457 · Received September 5, 2008

    Report

    Report Number
    3004209178-2008-05520
    Event Type
    Injury
    Date Received
    September 5, 2008
    Report Date
    August 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A SIGNIFICANT WEIGHT LOSS. THE PUMP FLIPPED SEVERAL TIMES WHICH THEN NEEDED TO BE "RETACKED DOWN". PLEASE REFER TO MFR'S REPORT #: 300420917820085521.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention PROGRAMMER MODEL 8840| CATHETER MODEL 8709| IMPLANTED| IMPLANTED| EXPLANTED| EXPLANTED| CATHETER MODEL 8578