BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-L 85-BP

    MDR report key: 2973495 · Received February 15, 2013

    Report

    Report Number
    1028232-2013-00315
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION WHICH OCCURRED MOST LIKELY DURING SURGERY. THE LEAD WAS RETURNED WITH AN INSERTED STYLET. AFTER REMOVING THE STYLET COAGULATED BLOOD WAS FOUND ON IT. THESE BLOOD RESIDUALS WERE MOST LIKELY INTRODUCED INTO THE LUMEN OF THE LEAD BY MEANS OF STYLETS USED DURING THE SURGERY AS WELL AS DUE TO THE CUTTINGS IN THE INSULATION. DURING FURTHER ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    DEVICE INTERROGATION INDICATED LV LEAD DISLODGMENT SINCE THE PREVIOUS DEVICE CHECK. SUBJECT AGREED TO A LEAD REVISION AND THIS WAS SCHEDULED FOR (B)(6) 2013. CURRENTLY THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS OBTAINED, THIS EVENT WILL BE UPDATED. (B)(6) 2013 - THIS LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2013 WITH ANOTHER LV LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69534 COROX OTW-L 85-BP LV LEAD NKE BIOTRONIK SE & CO. KG 368346

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization