BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922544 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12997
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    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) : NO ANOMALIES WERE FOUND. THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WAS BLOOD ON THE HELIX MECHANISM, THE HELIX WAS DISTORTED/ BENT, AND THERE WAS APPARENT EXPLANT DAMAGE. THE LEAD WAS RETURNED WITH THE HELIX FULLY ENGAGED AND STRETCHED. THE ANALYST NOTED THE HELIX WILL NOT FUNCTION PROPERLY BECAUSE IT IS STRETCHED AND SLIGHTLY BENT; AS A RESULT THE HELIX WILL NOT ENGAGE THE GUIDE TOOTH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO REPOSITION THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH THRESHOLDS AND NO CAPTURE. DURING THE PROCEDURE, THE HELIX BECAME STUCK AND THE LEAD WAS NOT REPOSITIONED. THE LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED. 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 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR