BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 121417 · Received September 17, 1997

    Report

    Report Number
    2124215-1997-09220
    Event Type
    Injury
    Date Received
    September 17, 1997
    Date of Event
    July 29, 1997
    Product Code
    LWS
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONCLUSION CPI RECEIVED A MEDWATCH FORM STATING: ICD SHOCK DUE TO SENSING OF MAKE BREAK CONTACT -NOISE-OVERSENSING REPRODUCED WITH CHANGES IN BODY POSTURE. THE ENDOTAK TRANSVENOUS DEFIBRILLATION LEAD (0064-001713) WAS REMOVED FROM SERVICE DUE TO OVERSENSING. A PORTION OF THE LEAD HAS BEEN RETURNED FOR ANALYSIS. LEAD RETURNED 9/12/97, ANALYSIS COMPLETED 11/14/97: LAB ANALYSIS: LEAD RETURNED SEVERED. FOUR SECTIONS RETURNED. YOKE SECTION NOT RETURNED. INSULATION DAMAGE. OUTER INSULATION ON EITHER SIDE OF THE WEBBING DAMAGE HAS ABRASION WEAR, NOTHING THROUGH. WEBBING DAMAGE MOST LIKELY CAUSED BY-CRUSHING-FROM THE CAN.

    Additional Manufacturer Narrative · 1

    EVENT CONCLUSION CPI RECEIVED A MEDWATCH FORM STATING: ICD SHOCK DUE TO SENSING OF MAKE BREAK CONTACT -NOISE-OVERSENSING REPRODUCED WITH CHANGES IN BODY POSTURE. THE ENDOTAK TRANSVENOUS DEFIBRILLATION LEAD WAS REMOVED FROM SERVICE DUE TO OVERSENSING. A PORTION OF THE LEAD HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LWS

    Patients

    Seq Age Sex Outcome Treatment
    1