BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1991538 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02427
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, ANALYZED, AND THERE WAS A TIP ELECTRODE MISCELLANEOUS (NON-ELECTRICAL). IT WAS ALSO NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR AND ON THE HELIX MECHANISM, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS AN OUTER INSULATION COSMETIC DEPRESSION, AND APPARENT EXPLANT DAMAGE. THE ANALYST ALSO NOTED THAT THE GUIDE TOOTH WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DISLODGMENT OF THE RIGHT VENTRICULAR LEAD. ATTEMPTS WERE MADE TO REPOSITION THE LEAD, BUT THERE WAS DIFFICULTY POSITIONING/FIXING IT. DOCTOR ALLEGES A PROBLEM WITH THE HELIX MECHANISM. IT WAS ALSO REPORTED THAT TWO PUNCTURES WERE MADE IN INSULATION AFTER DECIDING TO REMOVE THE LEAD. THE LEAD WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| VEDR01 IMPLANTABLE PULSE GENERATOR