BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRA CRT-P

    MDR report key: 3990777 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01762
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PRODUCTS: 694758 LEAD IMPLANTED: 2008 -(B)(6); 1788TC LEAD IMPLANTED: 2007 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE AND LEADS WERE REMOVED DUE TO BACTEREMIA AND A POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469559 SYNCRA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C2TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R 419478 LEAD