BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3111516 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07621
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4). FINAL ANALYSIS OF THE PUMP FOUND NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INCREASE IN PAIN. BOTH DYE AND ROTOR STUDIES WERE PERFORMED, DURING WHICH IT WAS SEEN THAT THE ROTORS DID NOT TURN. THE PUMP WAS TO BE EXPLANTED AS THE PHYSICIAN DID NOT THINK IT WAS WORKING. IT WAS ALSO FOUND THAT PRIOR TO EXPLANT, INTERROGATION SHOWED THAT THE PUMP SHOULD HAVE CONTAINED 12.6CC OF MEDICATION, BUT ACTUALLY CONTAINED 18CC. WHEN THE PUMP WAS EXPLANTED, THE DRUG WAS DRAINED FROM IT AND THE CATHETER AND PUT INTO THE NEW PUMP. THE PATIENT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS DELIVERING DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212924 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention