BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2812028 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05980
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 WITH NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS "FEELING WOOZY". IT WAS ALSO REPORTED THAT THE PHYSICIAN BELIEVES THAT THERE IS A HEADER/CONNECTOR ISSUE WITH THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD). IT WAS NOTED THAT THE PHYSICIAN THINKS IT WAS OVERSENSING AT THE CONNECTIONS AND THAT THE LEADS SPECIFICATIONS ARE ALL GOOD. IT WAS LATER REPORTED BY THE PATIENT THAT THE PATIENT'S ICD WAS "DEFECTIVE". THE ICD 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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD