BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2113828 · Received May 17, 2011

    Report

    Report Number
    3004209178-2011-03588
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PATIENT WAS HAVING BACK SURGERY, AND THE CATHETER WAS ACCIDENTALLY CUT. THE BACK SURGERY WAS NOT RELATED TO THE PUMP. THE NEED FOR A NEW CATHETER WAS DISCUSSED. ON (B)(6) 2011, IT WAS LATER REPORTED THAT THE SURGEON HAD SPLICED THE CATHETER BACK TOGETHER DURING THE SURGERY. THE PATIENT DID NOT HAVE A DISRUPTION OF INTRATHECAL INFUSION. THERE WERE NO PATIENT SYMPTOMS. THE PATIENT WAS NOT HOSPITALIZED; AND IT WAS NOTED THAT THERE WAS NO PATIENT INJURY. THE FOLLOWING DRUGS WERE ADMINISTERED VIA THE PUMP: DILAUDID, BUPIVACAINE, AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR CATHETER: MODEL 8596SC, LOT# N199814031| EXPLANTED:| CATHETER: MODEL 8598A, LOT# N217236009| IMPLANTED:| EXPLANTED:| IMPLANTED: