BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 1921759 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12687
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S8
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS 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 WHERE IT WAS DISCOVERED THAT THE OUTER INSULATION WAS BREACHED DUE TO ENVIRONMENTAL STRESS CRACKING. THE SEGMENT ALSO HAD OUTER INSULATION COSMETIC ENVIRONMENTAL STRESS CRACKING.

    Description of Event or Problem · 1

    FOLLOWUP WITH LAST KNOWN CLINICAL CONTACT WAS UNSUCCESSFUL TO DETERMINE WHY AND WHERE THE SYSTEM WAS REMOVED AS THE CLINIC HAD NOT SEEN THE PATIENT SINCE (B)(6) 2008. UPON COMPLETION OF ANALYSIS THE LEAD TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4003M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other A7700-21 HEART VALVE| ADSR01 IMPLANTABLE PULSE GENERATOR