BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2811627 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16865
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 5, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 DEVICE WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, A SET SCREW WAS LOOSE/DETACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A ROUTINE DEVICE CHANGE OUT, IT WAS DISCOVERED THAT THE ATRIAL LEAD WAS DISLODGED. THE LEAD WAS CAPPED AND REPLACED. WHEN THE PHYSICIAN CONNECTED THE NEW ATRIAL LEAD TO THE NEW DEVICE, THE PHYSICIAN WAS UNABLE TO ENGAGE THE SETSCREW OF THE NEW DEVICE. THE DEVICE WAS NOT IMPLANTED AND ANOTHER DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN 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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD