BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3210525 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11441
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 13, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER MIGHT HAVE BEEN KINKED, SO THAT THE PATIENT HAD NOT GOTTEN DRUG FOR A WEEK AND A HALF. AFTER THE PATIENT STARTED GETTING DRUG AGAIN, SHE ¿KIND OF OVERDOSED ON IT A LITTLE BIT¿. THE PUMP WAS THEN TURNED OFF BEFORE THE PATIENT WENT INTO WITHDRAWAL. AT THE TIME OF REPORT, THE OVERDOSE HAD RESOLVED, BUT THE PUMP HAD NOT BEEN TURNED BACK ON YET. IT WAS STATED THAT THE OVERDOSE SCARED THE PATIENT, SO SHE JUST NEEDED HER TIME TO GET THAT COMFORT LEVEL BACK. IT WAS REPORTED THAT THE PATIENT¿S FAMILY WANTED THE PUMP TO BE EXPLANTED, BECAUSE THEY HAD THOUGHT THAT THE OCCLUSION HAD CAUSED THE DRUG TO BACK UP UNTIL IT RELEASED, AT WHICH TIME, THE PATIENT RECEIVED A BIG BOLUS OF BUILT-UP DRUG. HOWEVER, THE REPORTER STATED THAT THEY WOULD PROBABLY KEEP THE PUMP IMPLANTED AND PERFORM A CATHETER REVISION, AS THE PATIENT HAD AN OLDER CATHETER IMPLANTED WHICH HAD KINKED TWICE. IT WAS STATED THAT THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. THE REPORTER THOUGHT THAT IT WAS GABLOFEN, BUT HE WASN¿T POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310635 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R