BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2200566 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11019
    Event Type
    Injury
    Date Received
    August 11, 2011
    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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 FOR (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. VARYING RESISTANCE/IMPEDANCE, RIGHT VENTRICULAR (RV) PACE IMPEDANCE VARIED BETWEEN ~480 OHMS AND ~1248 OHMS BETWEEN THE WEEK OF (B)(4)-2010 AND (B)(4)-2011. THE DEVICE WAS NOTE RETURNED, BUT DIAGNOSTIC INFORMATION IS CONSISTENT WITH REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM (ER) FOR SYNCOPE AND AT THAT TIME IT WAS NOTED THAT THERE WAS VARIABILITY AND A DECREASE IN THE LEAD IMPEDANCE SINCE THE LAST INTERROGATION. FURTHERMORE A FEW SHORT INTERVAL COUNTS WERE NOTED. IT WAS FURTHER REPORTED THAT THE DEVICE INHIBITED, CAUSING TWO PAUSES. UPON LEAD REVISION IT WAS DISCOVERED THAT THE LEAD WAS LOOSE IN THE DEVICE HEADER. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD