BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2220960 · Received August 23, 2011

    Report

    Report Number
    2182208-2011-02012
    Event Type
    Injury
    Date Received
    August 23, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD, PREVIOUSLY CAPPED AND REPLACED, HAS BEEN EXPLANTED DUE TO CARDIAC TRANSPLANT. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND ANALYSIS REVEALED THERE WAS A BREACHED DEPRESSION OF THE OUTER INSULATION. IT WAS NOTED THAT ALL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID IN THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), AND THE OUTER INSULATION WAS: BREACHED CUT, HAD A WHITE SUBSTANCE AND A COSMETIC DEPRESSION.

    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 ATRIAL LEAD HAD HIGH IMPEDANCE AND AN APPARENT FRACTURE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLDS. THE RIGHT ATRIAL LEAD WAS REMOVED AND REPLACED. THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED. 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 EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R 5380 COMPETITOR IMPLANTABLE PULSE GENERATOR| 5380 COMPETITOR IMPLANTABLE PULSE GENERATOR