BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2864889 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17551
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE OF THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT EXPOSED DEFIBRILLATION SUPERIOR VENA CAVA (SVC) CONDUCTOR WAS DISTORTED FROM BEING PULLED/STRETCHED/OVERSTRESSED AND THERE WAS APPARENT IMPLANT DAMAGE. THE ANALYST COMMENTED THAT THE SVC DEFIBRILLATION COILS WERE SEPARATED ON THE PROXIMAL END OF THE COIL. THE REPORT OF DAMAGE INDICATED THE LEAD WAS WITHDRAWN FROM A SAFE SHEATH INTRODUCER. THE SAFE SHEATH INTRODUCER IS DESIGNED TO HAVE THE LEAD INSERTED AND THEN THE INTRODUCER SPLIT OR SLIT OFF. THE COILS CAN BE DAMAGED BY PULLING THE LEAD OUT OF A SAFE SHEATH INTRODUCER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR [RV] LEAD INSULATION AND COIL WERE DAMAGED WHEN THE LEAD WAS PULLED OUT OF THE "OVERSIZED" INTRODUCER MULTIPLE TIMES. THE RV LEAD WAS REMOVED AND A DIFFERENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1