BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2358841 · Received December 5, 2011

    Report

    Report Number
    3004209178-2011-09603
    Event Type
    Injury
    Date Received
    December 5, 2011
    Report Date
    November 10, 2011
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL #: 8703, LOT# J93117819, SERIAL# UNK - CON'T IMPLANTED: UNK, EXPLANTED: UNK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS A LEAKING AT CONNECTOR; LEAK IDENTIFIED BY CATHETER DYE STUDY. IT WAS ADDED THAT PATIENT HAD GAINED 60 POUNDS AND EXPERIENCED SYMPTOMS OF INCREASED SPASTICITY, SHAKING, ITCHING, RHABDO, FEVER, TACHYCARDIA, HIGH RESPIRATORY RATE, 'FBP', AUTONOMIC DYSREFLEXIA. A DOSE ADJUSTMENT 'BOLUS/GOOD' AND A REVISION WAS DONE. PATIENT OUTCOME WAS NOTED AS SERIOUS INJURY. DRUG DELIVERED WAS GABLOFEN 2000MCG/ML.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL. NO ALARMS WERE NOTED. THE VOLUMES WERE CHECKED AND WERE EQUAL. A CT SCAN AND AN X-RAY WERE PERFORMED; THE RESULTS WERE NEGATIVE BUT THEY WERE NOT ABLE TO LOCATE THE TIP OF THE CATHETER DUE TO OTHER HARDWARE IMPLANTED IN THE PATIENT. THEY WERE ABLE TO ASPIRATE THE CATHETER. THE EVENT LOGS WERE NOTED TO BE NORMAL. THE HEALTH CARE PROVIDER PLANNED TO PERFORM DYE AND ROLLER STUDIES. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT IN THE HOSPITAL ON (B)(6) 2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    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 Hospitalization| R