BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1854741 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09330
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. (B)(4): THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT RECEIVED A SHOCK WHILE INSTALLING A CEILING FAN. THE PHYSICIAN WAS WONDERING IF ELECTRIC SHOCK COULD DAMAGE THE TISSUE AT THE END OF THE LEAD OR CAUSE A BURNING AT THE DEVICE POCKET. THE PATIENT HAS COMPLAINTS OF BURNING INSIDE HIS HEART WITH PACING; ATRIAL PACING CAUSES FEWER SYMPTOMS THAN VENTRICULAR PACING. THE PATIENT ALSO COMPLAINS OF SHOULDER PAIN AND A METAL TASTE IN MOUTH WHEN THE PACEMAKER PACES. A CHEST X-RAY SHOWED NO CHANGE IN THE LEAD POSITIONS. NO FURTHER 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 33 YR Required Intervention