BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1923121 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13253
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. EVALUATION SUMMARY; (B)(4) THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD IN/ON THE SLEEVEHEAD AND THE HELIX. (B)(4) THE FULL LEAD WAS RETURNED WHERE IT WAS DISCOVERED THAT THE DISTAL AND DEFIBRILLATION CONDUCTOR WERE DISTORTED. THERE WAS BLOOD IN/ON THE SLEEVEHEAD AND THE HELIX. THERE WAS BLOOD IN THE DISTAL CONDUCTOR NEAR THE LEAD ELECTRODE. THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION.

    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 DURING IMPLANT ATTEMPT, PHYSICIAN ATTEMPTED A LEAD IMPLANT IN THE RIGHT ATRIUM SEVERAL TIMES WITHOUT SUCCESS OF ATTACHMENT TO THE ATRIAL WALL. THE LEAD WAS REPLACED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED A LEAD IMPLANT IN THE RIGHT VENTRICLE SEVERAL TIMES, BUT AFTER SUCCESSFUL EXTENSION/RETRACTION OF THE ACTIVE FIXATION MECHANISM, IT WOULD NOT EXTEND. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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 63 YR Other