BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152457 · Received June 7, 2013

    Report

    Report Number
    3008973940-2013-00084
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD WAS EXPERIENCING INSUFFICIENT THRESHOLDS DURING IMPLANT. FLUOROSCOPY SHOWED THE SCREW WAS NOT FULLY EXTENDED. THE LEAD WAS REMOVED AND THE HELIX WAS TESTED. THE HELIX DID NOT IMMEDIATELY RESPOND, THEN "JUMPED" OUT COMPLETELY. THE PHYSICIAN DECIDED TO DISCARD THIS LEAD AND IMPLANT A NEW RV LEAD. PRIOR TO IMPLANT, THE HELIX OF THE NEW LEAD WAS TESTED AND THE SAME "JUMPING' WAS OBSERVED AS THE RV LEAD. THIS LEAD WAS DISCARDED AND A DIFFERENT MODEL REPLACEMENT WAS IMPLANTED. THE RIGHT ATRIAL (RA) LEAD DISLODGED DURING THE IMPLANT OF THE NEW RV LEAD AND WAS WITHDRAWN. THE HELIX WAS TESTED AND SHOWED THE SAME "JUMPING" AS THE RV LEAD. THIS LEAD WAS ALSO DISCARDED AND A NEW LEAD WAS IMPLANTED SUCCESSFULLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253065 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR