BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1132637 · Received August 22, 2008

    Report

    Report Number
    6000030-2008-05167
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 24, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1147-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS DIAGNOSED WITH INFLAMMATORY MASS. THE PUMP WAS GOING TO BE REPLACED. NO PT SYMPTOMS, TREATMENT, OR OUTCOME WAS REPORTED. THE DRUG CONTAINED IN THE PT'S PUMP WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HEALTHCARE PROVIDER, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709 LOT # J11388R56| IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNK