BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC ICD DEFIBRILLATOR

    MDR report key: 3051025 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-01020
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    February 6, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. CONCOMITANT PRODUCTS: 419388 IMPLANTABLE PACING LEAD 2002 (B)(6); 6944-65 IMPLANTABLE TACHY LEAD 2002 (B)(6); 5076-52 IMPLANTABLE PACING LEAD 2002 (B)(6); (B)(4) BI-VENTRICULAR DEFIBRILLATOR 2009 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED ENDOCARDITIS AND THAT THE LEFT VENTRICULAR EPICARDIAL LEAD AND ENTIRE BI-VENTRICULAR DEFIBRILLATION SYSTEM 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
    152129 INSYNC ICD DEFIBRILLATOR ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-60

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R