BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIROUET S+

    MDR report key: 3071755 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05267
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. PRODUCT: IMX49B45 IMPLANTABLE PACING LEAD (B)(6) 2000.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH IMPEDANCE AND NO CAPTURE IN BIPOLAR CONFIGURATION. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172765 PIROUET S+ DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI IMX49B52

    Patients

    Seq Age Sex Outcome Treatment
    1 ADDR01 IMPLANTABLE PULSE GENERATOR