BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1252019 · Received December 4, 2008

    Report

    Report Number
    6000030-2008-08017
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    January 1, 2007
    Report Date
    November 6, 2008
    Manufacturer
    RICE CREEK MANFUACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS CODE - USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CATHETER REVISION. NO OTHER INFO WAS PROVIDED AT THE TIME OF THE REPORT. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, 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 MANFUACTURING 8627 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709| PROGRAMMER: MODEL PROGRAMMER LOT# UNK