BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRA CRT-P

    MDR report key: 3160351 · Received June 10, 2013

    Report

    Report Number
    9614453-2013-01425
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 22, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. (B)(4): 5076 IMPLANTABLE PACING LEAD: 2003-(B)(6); 2188 IMPLANTABLE PACING LEAD 2001-(B)(6); 1488TC IMPLANTABLE PACING LEAD 2001-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED SEPSIS. THE LEFT VENTRICULAR (LV) LEAD, RIGHT VENTRICULAR (RV) LEAD AND THE IMPLANTABLEPULSE GENERATOR (IPG) WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259763 SYNCRA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C2TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R