BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2051251 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05517
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    November 10, 2010
    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
    DE, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING "PAIN" AFTER SURGERY WHICH LED TO "MULTIPLE AMBULANCE VISITS." FURTHER INVESTIGATION SHOWED THAT "ONE OF THE LEADS CAME LOOSE" (RIGHT VENTRICULAR LEAD DISLODGED). THE LEAD WAS REMOVED AND REPLACED "ABOUT 10 DAYS AFTER THE ORIGINAL SURGERY." 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 87 YR Hospitalization| R 5568 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR| ADDR01 IMPLANTABLE PULSE GENERATOR| 5568 IMPLANTABLE PACING LEAD