BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1863081 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10639
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    July 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    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 FOUND; BLOOD/BODY FLUID PRESENT ON THE PROXIMAL CONDUCTOR AND THE OUTER INSULATION WAS FOUND BREACHED CUT, APPARENT EXPLANT DAMAGE; FULL LEAD ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER IMPLANT, THE RV PACING LEAD DISLODGED. UNABLE TO PASS STYLET INTO LEAD DURING ATTEMPTS TO REPOSITION THE LEAD. THE LEAD WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A REESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER