BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2951555 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01570
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 1, 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
    MA, 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 DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 93% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. CONCOMITANT PRODUCTS: 0155, COMPETITOR IMPLANTABLE DEFIB LEAD, (B)(6) 2005; 4480, COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR AND THAT PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56030 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 00078 YR Hospitalization| R 4543 COMPETITORIMPLANTABLE PACING LEAD