BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2951667 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01579
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD: (B)(6) 2009. 4194 IMPLANTABLE PACING LEAD: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THERE WAS POSSIBLE EARLY BATTERY DEPLETION. IT WAS ALSO REPORTED THE DEVICE WAS PROGRAMMED FOR THE LEFT VENTRICULAR (LV) LEAD TO ADAPTIVE 1.5 TIMES WITH THE POLARITY OF LVRING TO RIGHT VENTRICULAR (RV) COIL AND THE LV LEAD HAD LOW IMPEDANCE WITH AN OUTPUT OF GREATER THAN 3 VOLTS, WHICH MAY HAVE CONTRIBUTED TO THE REDUCED BATTERY LONGEVITY. THE DEVICE WAS EXPLANTED AND REPLACED. THE LV LEAD IS STILL 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
    56232 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R 6947 IMPLANTABLE DEFIBRILLATION LEAD