BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1791123 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03043
    Event Type
    Injury
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND REVEALED THAT ON (B)(6) 2010 THE DEVICE RECORDED A VDD MONITOR AND VREG MONITOR POR (POWER ON RESET). ANALYSIS DETERMINED THAT DURING NORMAL OPERATION ON (B)(6) 2010 AN EVENT CAUSED A TRANSIENT HIGH CURRENT CONDITION ON VOLTAGE REGULATED SUPPLY FOR ANALOG AND DIGITAL CIRCUITS, RESULTING IN A MOMENTARY DECREASE IN REGULATED SUPPLY VOLTAGE. THE GLITCH DETECTION CIRCUIT INITIATED A POWER ON RESET FIRMWARE OPERATION. THESE POWER ON RESETS ARE POWER SUPPLY RATED AND TECH SERVICE RECOMMENDED THE DEVICE BE REMOVED. (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: FIRMWARE ERROR MESSAGE/CODE. ON (B)(6) 2010, DURING NORMAL OPERATION AN EVENT CAUSED A TRANSIENT HIGH CURRENT CONDITION ON THE VOLTAGE REGULATED SUPPLY FOR THE ANALOG AND DIGITAL CIRCUITS, RESULTING IN A MOMENTARY DECREASE IN REGULATED SUPPLY VOLTAGE. THE GLITCH DETECTION CIRCUIT INITIATED A POWER ON RESET FIRMWARE OPERATION. NORMAL BATTERY DEPLETION WAS ALSO NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A RECENT BODY SCAN AND THE CARELINK TRANSMISSION SHOWED THE DEVICE HAD AN ELECTRICAL RESET. RECOMMENDED DEVICE REPLACEMENT, AS THERE IS AN INTERNAL CIRCUIT PROBLEM. COULD BE THE RESULT OF AN INTERNAL SHORT DURING HIGH VOLTAGE CHARGING OR DELIVERY, OR A HIGH VOLTAGE EXTERNAL SHOCK THAT THE PATIENT HAD RECEIVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 4035 COMPETITOR IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD