BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2130663 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10208
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    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.

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED A RESISTANCE/IMPEDANCE INCREASE FOR BOTH LEADS. THERE WAS HIGH IMPEDANCE ON THE RIGHT VENTRICULAR LEAD STARTING THE WEEK OF (B)(4)-2011 AND ON THE ATRIAL LEAD STARTING THE WEEK OF (B)(4)-2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BRADYCARDIC. THE LEADS EXPERIENCED HIGH IMPEDANCE. THE RIGHT VENTRICULAR LEAD WAS NOT CAPTURING. THE LEADS WERE CAPPED AND REPLACED WITH NEW LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BRADYCARDIC. THE LEADS EXPERIENCED HIGH IMPEDANCE. THE RIGHT VENTRICULAR LEAD WAS NOT CAPTURING. THE LEADS WERE CAPPED AND REPLACED WITH NEW LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PATIENT HAD BRADYCARDIA. THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS HAD HIGH IMPEDANCE, AND THE RIGHT VENTRICULAR LEAD WAS NOT CAPTURING. THE LEADS WERE CAPPED AND REPLACED WITH NEW LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB