BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/16

    MDR report key: 1033771 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00388
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 21, 2008
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE ANALYSIS IS BASED ON THE INSPECTION OF THE QUAL DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE QUALITY DOCUMENTS SHOWED A REGULAR MFG PROCESS.

    Description of Event or Problem · 1

    PER REP, THIS LEAD WAS EXPLANTED DUE TO SUBCLAVIAN CRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK GMBH & CO. 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization