BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3163446 · Received June 11, 2013

    Report

    Report Number
    3007566237-2013-01937
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED AFTER CLONIDINE WAS PUT IN THE PUMP AND THE PATIENT SUBSEQUENTLY DEVELOPED SYMPTOMS. THE PATIENT STATED THE CLONIDINE BEING PUT IN THE PUMP WAS SUPPOSED TO HELP TO LOWER YOUR HEART RATE AND BLOOD PRESSURE, AND WHEN THEY PUT THE MEDICATION IN, IT ¿ABOUT KILLED ME¿, SO THEY TOOK IT OUT. THE PATIENT INDICATED WHEN THEY PUT THE CLONIDINE IN WITH THE DILAUDID, THEIR HEART RATE DROPPED DOWN TO 40 AND SHE THOUGHT SHE WAS GOING TO DIE. THE EVENT TOOK PLACE APPROXIMATELY 2 YEARS PRIOR TO THE REPORT, AND THE PATIENT REPORTED BEING DIZZY AND UNABLE TO STAND UP AT THE TIME OF THE EVENT, AS WELL AS IN THE HOSPITAL FOR 5 DAYS. THE PUMP WAS USED TO DELIVER DILAUDID AND CLONIDINE, AND THEN ONLY DILAUDID WHEN CLONIDINE WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263769 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| L