BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2951471 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01550
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PRODUCT: 2187 IMPLANTABLE PACING LEAD, (B)(6) 2006, 1688T COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 2006, 5076 IMPLANTABLE PACING LEAD, (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND THE RESULTS WERE INCONCLUSIVE. BASED ON THE DESTRUCTIVE ANALYSIS RESULTS, NO INTERNAL SHORT OCCURRED IN THE BATTERY AND NO EVIDENCE WAS FOUND OF A CONDITION THAT WOULD CAUSE A HIGH INTERNAL CURRENT DRAIN.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A HEART RATE IN THE 20 BEATS PER MINUTE RANGE AND COMPLETE HEART BLOCK. THE DEVICE WAS UNABLE TO BE INTERROGATED EITHER WIRED OR WIRELESS AND NO PACING WAS SEEN. IT WAS NOTED THE REMOTE MONITORING TRANSMISSION FROM FIVE MONTHS PRIOR SHOWED A BATTERY STATUS OF 3.04 VOLTS AND THE BATTERY WAS THOUGHT TO HAVE BEEN 2.70 VOLTS TWO MONTHS PRIOR TO THE PATIENT PRESENTING. THE DEVICE HAD POSSIBLE EARLY BATTERY DEPLETION. THE PATIENT RECEIVED A TEMPORARY PACEMAKER UNTIL BEING EVALUATED FOR A DEVICE CHANGE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56010 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 00088 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD