BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRHOMED II

    MDR report key: 1161186 · Received September 15, 2008

    Report

    Report Number
    3004209178-2008-05768
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCP ENCOUNTERED DIFFICULTY ACCESSING CENTER PORT OF THE PUMP DURING REFILL. ONLY THE METAL WAS FELT WHEN INSERTING REFILL NEEDLE. THE APPROPRIATE KIT AND NEEDLES WERE USED. IT WAS SUBSEQUENTLY DETERMINED THAT THE PUMP HAD FLIPPED. THE PUMP WAS SURGICALLY REVISED AND THE PUMP WAS REFILLED. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| CATHETER MODEL 8709SC LOT# N144200018| PROGRAMMER MODEL 8840 LOT# UNKNOWN