BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 3862336 · Received June 10, 2014

    Report

    Report Number
    3008973940-2014-00208
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCTS: 1888TC LEAD IMPLANTED (B)(6) 2010; 7122 LEAD IMPLANTED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STYLET BECAME LODGED IN THE NEWLY IMPLANTED LEFT VENTRICULAR (LV) LEAD AFTER CUTTING THE DELIVERY SYSTEM AND REQUIRED GREAT FORCE TO REMOVE. THE STYLET TOOK ON A SINUSOIDAL SHAPE WHEN REMOVED. THE PHYSICIAN BELIEVED THAT THIS LEFT PENT UP TORQUE IN THE LEAD AND MAY HAVE CONTRIBUTED TO THE LEAD DISLODGING BY THE FOLLOWING MORNING. THE LEAD WAS SUBSEQUENTLY REMOVED. A NEW LEAD WAS SUCCESSFULLY PLACED IN THE TARGET POSITION. THE STYLET BECAME STUCK FOLLOWING SLITTING AND REMOVAL OF THE DELIVERY SYSTEM. SIGNIFICANT FORCE WAS REQUIRED TO SLOWLY PULL THE STYLET OUT OF THE LEAD AND A CONSTANT FRICTION-TYPE NOISE COULD BE HEARD, SIMILAR TO THAT OF UNROLLING MASKING TAPE. ONCE REMOVED, THRESHOLDS REMAINED UNCHANGED AND THE LEAD REMAINED IN THE TARGET POSITION. HOWEVER, LEAD SLACK IN A FIGURE EIGHT SHAPE WAS OBSERVED IN THE CORONARY SINUS BODY, PRESUMABLY FROM THE RELEASE OF TORQUE FROM THE PROLONGED TENSION DURING STYLET REMOVAL. CONCERN WAS THEN EXPRESSED AS TO WHETHER THE STYLET WAS OF THE CORRECT DIAMETER FOR THE LEAD LUMEN. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338419 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC SINGAPORE OPERATIONS 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR DTBA201 ICD