BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2532259 · Received April 12, 2012

    Report

    Report Number
    6000144-2012-02449
    Event Type
    Malfunction
    Date Received
    April 12, 2012
    Date of Event
    February 20, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THE SET SCREW WAS IN THE CONNECTOR BORE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE THE LEAD INTO THE HEADER OF THE DEVICE, BUT IT WOULD NOT ADVANCE INTO THE PIN CONNECTOR. THE LEAD WAS REMOVED AND IT WAS OBSERVED THAT THE SETSCREW HAD ADVANCED FULLY INTO THE BORE OF THE CONNECTOR BLOCK. AN ATTEMPT WAS MADE TO REVERSE OUT THE SETSCREW BUT IT WAS NOT POSSIBLE. A NEW DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD