BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 3001933 · Received March 13, 2013

    Report

    Report Number
    1028232-2013-00662
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    July 26, 2012
    Report Date
    February 22, 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 UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. ITS PERFORMANCE WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION DEMONSTRATED THAT THE LEAD'S DISTAL PART WAS PULLED OUT OF THE RING ELECTRODE. THEREFORE, THE ADHESIVE RESIDUALS ON THE JOINING SURFACE OF LEAD TIP AND THE LEAD BODY WERE ANALYZED. THE ANALYSIS REVEALED NO INDICATION OF A MATERIAL OR A MANUFACTURING PROBLEM. AS THE ROOT CAUSE OF THE OBSERVED DAMAGE TRACTION FORCES DURING THE SURGERY SHOULD BE TAKEN INTO CONSIDERATION. IN ADDITION, CUTTINGS IN THE INSULATION WERE FOUND. DURING FURTHER ANALYSIS, NO FURTHER 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

    THIS LEAD BECAME DISLODGED AND THE PHYSICIAN ATTEMPTED TO REPOSITION IT, BUT WAS UNABLE TO DUE TO POOR CS ANATOMY. THIS LEAD WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105845 COROX OTW-S 85-BP LV LEAD NKE BIOTRONIK SE & CO. KG 355149

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization