BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 2123429 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02266
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    Z-0111-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ADDITIONAL ANALYSIS WAS PERFORMED ON THE DEVICE. NO ANOMALIES WERE OBSERVED. THE DEVICE WAS FOUND TO BE FUNCTIONAL WITH NOMINAL CURRENT DRAIN WHEN POWERED WITH AN EXTERNAL SUPPLY. NO ELECTRICAL FAILURES WERE NOTED. NO ANOMALIES ALONG THE PERIMETER OF THE STACKED CHIP SCALE PACKAGE WERE OBSERVED DURING OPTICAL INSPECTION AFTER REMOVING ALL THE SURROUNDING COMPONENTS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THE ANALYSIS WAS INCONCLUSIVE. THE DEVICE LOST TELEMETRY AND FUNCTION DUE TO BATTERY DEPLETION. THE CAUSE OF THE DEPLETION CANNOT BE DETERMINED. THE DEVICE WAS FULLY FUNCTIONAL AND OPERATED UNDER NORMAL CURRENT DRAIN WHEN POWERED WITH AN EXTERNAL SUPPLY. THE RESIDUAL VOLTAGE AND IMPEDANCE INDICATES THAT THE BATTERY WAS NOT INTERNALLY SHORTED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE BATTERY FROM THE DEVICE WAS ANALYZED. BASED ON THE DESTRUCTIVE ANALYSIS RESULTS, NO INTERNAL SHORT OCCURRED IN THE BATTERY AND NO EVIDENCE WAS FOUND OF AN INTERNAL CONDITION THAT WOULD CAUSE A HIGH INTERNAL CURRENT DRAIN. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED PREMATURE BATTERY DEPLETION WHILE ON THE SHELF IN THE BOX. THE ICD WOULD NOT ESTABLISH COMMUNICATION WITH THE PROGRAMMER AND WAS UNABLE TO BE INTERROGATED FROM A WIRED OR WIRELESS TELEMETRY OPTION; THEREFORE THE ICD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other