BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2133546 · Received June 15, 2011

    Report

    Report Number
    3004209178-2011-04444
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED "WITHDRAWAL TYPE SYMPTOMS" SHORTLY AFTER HAVING A PUMP REPLACED. THE HCP FOUND A SMALL HOLE IN THE CATHETER JUST DISTAL TO THE SUTURELESS CONNECTOR. THE HCP CUT OFF THE CATHETER JUST DISTAL TO THAT HOLE AND REATTACHED THE CONNECTOR. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL SINCE THE HOLE WAS DISCOVERED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE REPORTED IF IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709, LOT# J55502R15| IMPLANTED: