BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2914508 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00580
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    January 11, 2013
    Manufacturer
    MDT 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL: 8709SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS NOTED THAT THERE WAS NO CHANGE IN THERAPY AND THAT THE DOCTOR PUT THE PUMP IN A MESH POUCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS "FLIPPED/SLIPPED" AND PATIENT WAS UNDERGOING A REVISION. PER REPORTER, THE HEALTHCARE PROVIDER (HCP) WAS INTENDING TO PUT IN A POUCH AND A REVISION WAS BEING DONE AS OF THE DATE OF THIS REPORT. IT WAS ALSO INDICATED THAT THE CATHETER HAD MIGRATED UPWARDS WHICH WAS "ACTUALLY A GOOD THING" AS THE PATIENT WAS HAPPY WITH RESULTS THAT SHE WAS GETTING NOW. NO CATHETER REVISION WAS INDICATED. DRUG DELIVERED WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20388 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention