BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1924196 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13457
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT 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) DAMAGE, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENTIRE SYSTEM WAS EXPLANTED DUE TO VEGETATION IDENTIFIED ON THE RIGHT VENTRICULAR LEAD, AND INFECTION AND ENDOCARDITIS WERE ALSO REPORTED. CULTURE TESTING REVEALED METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS. IT WAS ALSO REPORTED THAT CHRONICALLY LOW IMPEDANCE MEASUREMENTS AND INTERMITTENT UNDERSENSING OF P-WAVES WAS OBSERVED ASSOCIATED WITH THE RIGHT ATRIAL LEAD. IT WAS ALSO REPORTED THAT NOISE WAS OBSERVED ON A NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODE ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD . BOTH LEADS WERE EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE SYSTEM WAS LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS VEGETATION IDENTIFIED ON THE RIGHT VENTRICULAR LEAD, AND INFECTION AND ENDOCARDITIS WERE ALSO REPORTED. CULTURE TESTING REVEALED (B)(6). IT WAS ALSO REPORTED THAT CHRONICALLY LOW IMPEDANCE MEASUREMENTS AND INTERMITTENT UNDERSENSING OF P-WAVES WAS OBSERVED ASSOCIATED WITH THE RIGHT ATRIAL LEAD. IT WAS ALSO REPORTED THAT NOISE WAS OBSERVED ON A NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODE ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD . BOTH LEADS WERE EXPLANTED AND NOT 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 SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4524 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB