BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2865028 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17638
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE RIGHT VENTRICULAR EXPOSED DEFIBRILLATION COIL WAS PULLED/STRETCHED/OVERSTRESSED. IT WAS NOTED THAT THERE WAS BLOOD ON THE DISTAL ELECTRODE AND THE LEAD APPEARED TO BE DAMAGED AT IMPLANT. CONCOMITANT PRODUCTS 5068 IMPLANTABLE PACING LEAD (B)(6) 2000; ADDR01 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD THE DISTAL END OF THE COIL UNRAVELED UPON INSERTION THROUGH THE 9FRENCH SHEATH. THE LEAD WAS NOT USED AND ANOTHER 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 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR 5068 IMPLANTABLE PACING LEAD