BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1875138 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11636
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    March 5, 2007
    Report Date
    February 28, 2024
    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
    NM, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    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. HOSPITAL INFORMATION ADDED. EVENT DESCRIPTION UPDATED. CORRECTED EVENT LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE HAS PAIN AND DISCOMFORT IN THE DEVICE LOCATION. THE SENSATION HAS BEEN INTERMITTENT FOR THE PAST COUPLE OF MONTHS. NO OUTWARD PROBLEMS WERE SEEN AND NO KNOWN INJURY. THE PATIENT FURTHER REPORTED THERE WAS ELECTROMAGNETIC INTERFERENCE (EMI) FROM AN ELECTRIC TOOTHBRUSH. IT WAS ALSO REPORTED BY THE PATIENT THAT FOLLOWING THE IMPLANT THE WIRES CAME LOOSE AND MAY HAVE PUNCTURED THE LUNG. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE CONFIRMED A PNEUMOTHORAX OCCURRED DURING THE IMPLANT PROCEDURE. ADDITIONALLY, LATER IN THE EVENING AFTER THE PROCEDURE, THE PATIENT HAD A FALL IN THE HOSPITAL. A CT SCAN WAS DONE AND EVERYTHING WAS "FINE". THERE WAS NO EVIDENCE THAT THE DEVICE CAUSED THE FALL. IT WAS DISCOVERED THE DAY AFTER SURGERY THAT THE RIGHT VENTRICULAR LEAD HAD DISLODGED AND THE LEAD WAS REPOSITIONED. BOTH LEADS REMAIN IN USE, AND THE DEVICE REMAINS IN USE. 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 79 YR Female Required Intervention