BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET TIP

    MDR report key: 4162638 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12685
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K894040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 MEDICAL PRODUCTS: A 5076-52 LEAD, (B)(6) 2008. A 7122 LEAD: (B)(6) 2013. A 1582 COMPETITOR LEAD: (B)(6) 2008. A 435-05 COMPETITOR LEAD: (B)(6) 1996. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED ENDOCARDITIS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEADS WERE EXPLANTED AND A TEMPORARY PACING LEAD WAS PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644368 TARGET TIP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4081-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Hospitalization| R DDBB1D1 ICD