BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2813485 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16529
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE INNER INSULATION HAD BREACHED METAL ION OXIDATION (MIO). IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS MELTED, THE INNER INSULATION HAD COSMETIC METAL ION OXIDATION (MIO), THE OUTER INSULATION HAD COSMETIC METAL ION OXIDATION (MIO), THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THE TINES/LOBES WERE CUT. (B)(4) THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE INNER INSULATION HAD BREACHED METAL ION OXIDATION (MIO). IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS MELTED, THE INNER INSULATION HAD COSMETIC METAL ION OXIDATION (MIO), THE OUTER INSULATION HAD COSMETIC METAL ION OXIDATION (MIO), THE OUTER INSULATION WAS BREACHED AND HAD ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLD ALONG WITH LOW IMPEDANCE. THE RIGHT ATRIAL (RA) LEAD ALSO HAD LOW IMPEDANCE AND SEVERAL HIGH RATE EPISODES DUE TO INTERMITTENT OVERSENSING OF THE VENTRICULAR OUTPUT. THE RV AND RA LEADS WERE EXPLANTED 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 SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R KDR903 IMPLANTABLE PULSE GENERATOR