BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1923193 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13301
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 12, 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
    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: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 374 HIGH IMPEDANCE PACES RECORDED AFTER VENTRICULAR LEAD WARNING ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD DEVELOPED LOSS OF CAPTURE SHORTLY AFTER IMPLANT. WHEN THE LEAD WAS REPOSITIONED, THE LEAD WAS ABLE TO BE PULLED BACK BEFORE THE HELIX WAS RETRACTED, SO A MICRO-DISLODGEMENT WAS SUSPECTED. ALSO DURING THE REPOSITIONING PROCEDURE, THE LEAD WAS DETERMINED TO BE ENTERING THE CORONARY SINUS WITH MARGINAL, UNSTABLE PACING AND SENSING. THE FINAL POSITION IN THE APEX HAD EXCELLENT FUNCTION. THE LEAD IS STILL 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 57 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR