BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1875380 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05499
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    July 2, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND DURING ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 EAS RETURNED AND ANALYZED. PRIMARY RESULTS REVEALED THAT NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL PACE/SENSE LEAD HAD "LOW" SENSING AT IMPLANT ONCE IT WAS CONNECTED TO THE DEVICE. THE PHYSICIAN DECIDED TO REPOSITION THE LEAD. WHEN HE ATTEMPTED TO RECONNECT IT TO THE DEVICE, THE SETSCREW IN THE DEVICE "COULD NOT BE TIGHTENED." IT WAS ALSO REPORTED THAT, BECAUSE OF THE SETSCREW PROBLEM, THE DEVICE HAD TO BE REMOVED AND REPLACED BY A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL PACE/SENSE LEAD HAD "LOW" SENSING AT IMPLANTED ONCE IT WAS CONNECTED TO THE DEVICE. THE PHYSICIAN DECIDED TO REPOSITION THE LEAD. WHEN HE ATTEMPTED TO RECONNECT IT TO THE DEVICE, THE SETSCREW IN THE DEVICE "COULD NOT BE TIGHTENED." IT WAS ALSO REPORTED THAT, BECAUSE OF THE SETSCREW PROBLEM, THE DEVICE HAD TO BE REMOVED AND REPLACED BY A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R