BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 658232 · Received November 23, 2005

    Report

    Report Number
    6000030-2005-01839
    Event Type
    Injury
    Date Received
    November 23, 2005
    Report Date
    November 21, 2005
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PUMP INTERROGATION REVEALED "MULTIPLE STOPS". A CAPSULOTOMY WAS PERFORMED AND THE PUMP WAS EXPLANTED ON 11/19/2005. THE PT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE DEVICE WAS EXPLANTED. NO REASON WAS GIVEN FOR THE EXPLANT. THE DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS. 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 EL PUMP LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization