BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 3152392 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06832
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. CONCOMITANT PRODUCTS: D274TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2011; 1388TC COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2000; 1388TC COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2003; 1258T COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 201. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD POSSIBLE PREMATURE BATTERY DEPLETION. IT WAS NOTED THAT RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) OUTPUTS WERE HIGH. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEADS REMAIN 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
    253010 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR