BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1002339 · Received February 22, 2008

    Report

    Report Number
    3004209178-2008-00882
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT'S DAUGHTER REPORTED THAT THE PT WAS ADMITTED TO THE HOSPITAL DUE TO SLEEPINESS AND DIARRHEA. A PUMP ALARM WAS HEARD, BUT TELEMETRY HAD NOT YET BEEN PERFORMED. THE HCP REPORTED THAT THE PT HAD AN ALTERED MENTAL STATUS AND WAS "OBTUNDED". TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING DUE TO A MOTOR STALL. THE PT WAS RECEIVING COMPOUNDED MORPHINE VIA THE PUMP. NO DIAGNOSTIC STUDIES HAD YET BEEN PERFORMED. THE PT'S DAUGHTER FURTHER REPORTED THAT THE PT HAD ALSO BEEN VOMITING. SHE ALSO REPORTED THAT UNSPECIFIED DIAGNOSTIC STUDIES HAD BEEN DONE. SHE WAS ENCOURAGED TO CONTACT HER MOTHER'S HCP. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R EXPLANTED| CATHETER MODEL 8711 LOT # L78728| IMPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED| IMPLANTED