BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2203091 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11634
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S10
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD HAD AN INSULATION BREECH. THE LEAD WAS REPAIRED AND IS STILL IN USE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD AN INSULATION BREECH AT SOME POINT IN THE PAST. NO FURTHER INFORMATION WAS AVAILABLE FROM THE CLINIC AS TO WHEN THE INSULATION BREECH OCCURRED. THE LEAD HAD BEEN REPAIRED AND IS STILL 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4023 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB