BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3398209 · Received October 9, 2013

    Report

    Report Number
    2649622-2013-11166
    Event Type
    Injury
    Date Received
    October 9, 2013
    Report Date
    August 6, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 PRODUCT: 4592, IMPLANTABLE PACING LEAD, (B)(6) 2005-06-02. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD HAD A WIDE SPREAD OF IMPEDANCES WITH 1100 OHMS BIPOLAR AND 206 OHMS UNIPOLAR. IT WAS NOTED THAT THE LEAD APPEARED TO BE PACING AND SENSING APPROPRIATELY. THE RV LEAD IS PLANNED TO BE REPLACED DURING AN UPCOMING ROUTINE DEVICE CHANGE OUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513580 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 4092

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R E2DR01AA IMPLANTABLE PULSE GENERATOR