BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 3152448 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01555
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 1, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWS
    PMA / PMN Number
    P980050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT PRODUCTS: D284TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2010; 4196 IMPLANTABLE PACING LEAD (B)(6) 2010; 5076 IMPLANTABLE PACING LEAD (B)(6) 2010; 6935 IMPLANTABLE TACHY LEAD (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PATIENT ALARM FOR HIGH SUPERIOR VENA CAVA (SVC) IMPEDANCE. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253017 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS RICE CREEK MFG 6937A-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR