BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1991886 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02608
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD). IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE HELIX/LOBE WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION AND THE LEAD APPEARED DAMAGED AT IMPLANT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TWO REPOSITIONING ATTEMPTS DURING THE IMPLANT PROCEDURE, THE HELIX WOULD NOT EXTEND WITH MORE THAN TWENTY-FIVE ROTATIONS. IT WAS ALSO REPORTED THAT THE HELIX "POPPED OUT"ONCE THE LEAD WAS REMOVED FROM THE PATIENT. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TWO REPOSITIONING ATTEMPTS DURING THE IMPLANT PROCEDURE, THE HELIX WOULD NOT EXTEND WITH MORE THAN TWENTY-FIVE ROTATIONS. IT WAS ALSO REPORTED THAT THE HELIX "POPPED OUT" ONCE THE LEAD WAS REMOVED FROM THE PATIENT. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE DOCTOR WAS NOT SATISFIED WITH THE R-WAVE MEASUREMENTS UPON THE FIRST POSITIONING ATTEMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other