BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3991539 · Received August 8, 2014

    Report

    Report Number
    3008973940-2014-00260
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE TABS REMOVED FROM THE ANCHORING SLEEVE. AN OUTER INSULATION EXTRINSIC CUT WAS ALSO OBSERVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE RIGHT ATRIAL (RA) LEAD DISLODGED. ONE DAY POST IMPLANT DURING A DEVICE CHECK THE LEAD WAS FOUND TO HAVE MOVED AGAIN. THE LEAD WAS REPOSITIONED. SUBSEQUENTLY THE PATIENT PRESENTED TO THE HOSPITAL NOT FEELING WELL AND WITH SHORTNESS OF BREATH, AND UPON EXAMINATION IT WAS FOUND THAT THE LEAD HAD MOVED. THE PHYSICIAN WAS CONCERNED THAT THE ANCHOR SLEEVE WAS NOT HOLDING THE LEAD IN PLACE ONCE TIGHTENED; THE LEAD SLIPS IN THE SLEEVE AND DISLODGES. THE PHYSICIAN FELT THAT THE DESIGN OF THIS MODEL LEAD MAY CAUSE HIGHER THAN NORMAL DISLODGEMENT RATES, AS THE LEAD HAS A SMALLER DIAMETER AND IS MADE WITH A MATERIAL THAT MAY HAVE A LOWER COEFFICIENT OF FRICTION WITH THE SUTURE SLEEVE. THERE IS ALSO CONCERN THAT APPLYING EXTRA TENSION TO SUTURES HAS THE POTENTIAL TO DEFORM THE LEAD BODY. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REP ORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469588 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 457453

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R