BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1923107 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13241
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    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 PROXIMAL PORTION OF THE LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. IT WAS NOTED THAT THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTING). APPARENT EXPLNAT DAMAGE WAS PRESENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD OPEN HEART SURGERY TWO DAYS AFTER HAVING THEIR PACEMAKER AND LEADS IMPLANTED. THE LEAD BECAME DISLODGED AND DAMAGED DURING THE SURGERY. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT 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. 5592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R 5092 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR