BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1921472 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12546
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE TRENDED HIGHER OVER THE LAST FEW YEARS. ALSO WHILE TESTING THE RV LEAD DURING THE DEVICE CHANGEOUT, THE PROXIMAL PORTION OF THE LEAD DISCONNECTED FROM THE DISTAL PORTION WHICH WAS LEFT IN THE PATIENT. THE LEAD WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5054 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention KDR701 IMPLANTABLE PULSE GENERATOR| 5554 IMPLANTABLE PACING LEAD