BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2122494 · Received June 13, 2011

    Report

    Report Number
    2647346-2011-00795
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    January 18, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. EVALUATION SUMMARY: (B)(4) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE ICD DEVICE AND HAVE ANALYZED THIS DATA. HIGH IMPEDANCE WAS NOTED. OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERT IS OBSERVED ON (B)(6) 2011. INTERFERENCE/NOISE WAS NOTED. HIGH VENTRICULAR SHORT INTERVAL COUNT (SIC) IS OBSERVED WITH 510 COUNTS OCCURRING BETWEEN THE (B)(6) 2011 AND THE (B)(6) 2011. ZERO COUNTS ARE RECORDED BETWEEN THE (B)(6) AND THE (B)(6) 2011. HIGH SIC CAN INDICATE THE PRESENCE OF NOISE OR INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD AN APPARENT FRACTURE OR A BREACH. THERE WAS OVERSENSING (NOISE), NON-SUSTAINED TACHYCARDIA AND VENTRICULAR TACHYCARDIA EPISODES BUT NOT THERAPY. IT WAS ALSO REPORTED THERE WAS INHIBITION OF PACING AND THE LEAD HAD OVER AND UNDER SENSING. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED BY A NEW PACE/SENSE LEAD. THE HIGH VOLTAGE PART OF THE LEAD IS STILL IN USE. IT WAS FURTHER REPORTED THERE WAS ASYSTOLE. IT WAS ALSO REPORTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MALFUNCTIONED. THE ICD DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN 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 85 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD