BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2952461 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00572
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 9, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: (B)(6)2011, 5068, IMPLANTABLE PACING LEAD, (B)(6) 1997; 1258T, IMPLANTABLE PACING LEAD, (B)(6) 2011; 6935, IMPLANTABLE DEFIBRILLATION LEAD, (B)(6) 2011. (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 NOISE WAS OBSERVED IN THE RIGHT VENTRICULAR LEAD. DURING ISOMETRIC TESTING WHEN THE RIGHT VENTRICULAR (RV) SENSING WAS BIPOLAR, THE LEAD NOISE LED TO ASYSTOLE IN A PACEMAKER DEPENDENT PATIENT. THE LEAD WAS CAPPED AND THE PACE/SENSE PORTION OF THE EXISTING DEFIBRILLATION LEAD WAS ACTIVATED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57808 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5024M-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Hospitalization| L| R (B)(4) IMPLANTABLE BI-VENTRICULAR DEFIBRILLATOR