BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2888913 · Received December 28, 2012

    Report

    Report Number
    3004209178-2012-12333
    Event Type
    Injury
    Date Received
    December 28, 2012
    Report Date
    November 28, 2012
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER: PRODUCT ID 8 590-1, LOT# N230604, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGICAL REVISION TOOK PLACE TO REPOSITION A FLIPPED PUMP. THE REVISION TOOK PLACE ON (B)(6) 2012. THE PATIENT WAS SUSPECTED OF BEING A "TWIDDLER." THE PUMP WAS REVISED IN (B)(6) 2009 AND A MESH POUCH WAS ADDED TO TRY AND HELP IT SCAR IN. AT THE TIME OF THE REPORT THE POUCH WAS STILL SECURELY ATTACHED TO THE PUMP BUT WAS NOT ATTACHED TO ANY TISSUE IN THE PATIENT. THE DOCTOR FLIPPED THE PUMP OVER AND RE-SUTURED IT DOWN FACING UP. THERE WERE NO PATIENT SYMPTOMS. THE PUMP WAS REFILLED DURING THE CASE AND THE PATIENT RECOVERED WITHOUT SEQUELAE. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN (BACLOFEN).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention