BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991376 · Received August 8, 2014

    Report

    Report Number
    3008973940-2014-00261
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PACING LEAD WAS EXHIBITING VARYING THRESHOLD MEASUREMENTS IN THE DAYS AFTER IMPLANT. DURING THE PROCEDURE TO REVISE THE LEAD, THE LEAD EXHIBITED NO CAPTURE WHEN CONNECTED TO AN ANALYZER BUT DID CAPTURE WHEN CONNECTED TO THE IMPLANTABLE PULSE GENERATOR (IPG) ALTHOUGH PECTORAL MUSCLE STIMULATION WAS ALSO OBSERVED. INSULATION DAMAGE WAS SUSPECTED SO THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469840 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R