BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 2914104 · Received December 7, 2012

    Report

    Report Number
    1028232-2012-03163
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 28, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MFR OF THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BENN 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. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MFG.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF ABOUT 45 MONTHS HIGH PACING IMPEDANCES (OVER 2000 OHMS) AND LOSS OF CAPTURED WERE NOTED. NO ADVERSE PT SIDE EFFECTS WERE REPORTED. THE LEAD WAS NOT EXPLANTED. THE EVENT DATE WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization