BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2864771 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17504
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    September 20, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER WITH NO INFORMATION AFTER BEING EXPLANTED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. FOLLOW UP WAS ATTEMPTED TO OBTAIN THE REASON FOR EXPLANT BUT WAS UNSUCCESSFUL. 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 MEDTRONIC 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD)