BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2203483 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12347
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ACUTE THRESHOLD RISE OBSERVED ON BOTH THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIUM (RA) LEAD TRENDS. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE INTERROGATION REVEALED THAT THE ATRIAL SENSED SIGNAL COINCIDED WITH THE VENTRICULAR SENSED SIGNAL, AS WELL AS NO ATRIAL PACING CAPTURE. THE PATIENT REPORTED FATIGUE AND THUMPING/POUNDING IN THE CHEST. THEREFORE THE DEVICE WAS PROGRAMMED TO VVI 40. FURTHERMORE, IT WAS REPORTED THAT THE RA LEAD DISLODGED, AND DURING REPOSITIONING OF THE RA LEAD THE RV LEAD MOVED AND WAS ALSO REQUIRED TO BE REPOSITIONED. BOTH THE DEVICE AND LEADS REMAIN 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
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R