BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1252020 · Received December 4, 2008

    Report

    Report Number
    3004209178-2008-08018
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    January 1, 2007
    Report Date
    November 5, 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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHORTLY AFTER THE DEVICE WAS IMPLANTED, THE PATIENT HAD A PROCEDURE TO ASPIRATE THE PUMP POCKET. THE PATIENT STATED THAT THE INCISION WAS CLOSED WITH GLUE AND SHE IS ALLERGIC TO GLUE. SHE FURTHER INDICATED THAT THE INCISION 'BLEW OPEN' AND WAS SEEPING BROWN COLORED DRAINAGE. THE PATIENT REPORTED EXPERENCING SYMPTOMS OF INABILITY TO SLEEP, CONTRACTIONS 'SIMILAR TO HARD LABOR' AND SEVERE HEADACHES AS WELL AS A RETURN OF SYMPTOMS. THE PUMP WAS USED TO DELIVER DILAUDID AND BUPIVICAINE (CONCENTRATION AND DOSAGE WERE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention CATHETER: MODEL 8578| EXPLANTED| PROGRAMMER: MODEL 8840 LOT# UNK| CATHETER: MODEL 8711| EXPLANTED