BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1101847 · Received August 7, 2008

    Report

    Report Number
    3004209178-2008-04765
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    November 10, 2007
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER LEFT IN PLACE AND KNOTTED DURING SURGERY TO EXPLANT THE PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS EXPLANTED DUE TO AN INFECTED PUMP POCKET. THE CATHETER WAS LEFT IN PLACE AND KNOTTED. SPECIFIC SYMPTOMS WERE NOT REPORTED. THE PT WAS TREATED WITH ANTIBIOTICS. THE PT RECOVERED WITHOUT SEQUELA.

    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 73 YR Required Intervention IMPLANTED:| CATHETER MODEL 8711 LOT# N103704006| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK