BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1791060 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07020
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    March 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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): PRIMARY ANALYSIS FINDING: DEFIB CONDUCTOR DISTORTED. THE FULL LEAD WAS RETURNED AND ANALYZED. VISUAL EXAMINATION REVEALED THAT THE DISTORTED EXPOSED DEFIB CONDUCTOR COILS WOULD NOT AFFECT THE LEAD PERFORMANCE. THE DAMAGE MOST LIKE OCCURRED DURING THE IMPLANT ATTEMPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS DAMAGED PRIOR TO USE DUE TO THE PHYSICIAN PUSHING AND PULLING HARD ON THE LEAD IN THE INTRODUCER. THE LEAD WAS NOT IMPLANTED AND A DIFFERENT LEAD WAS USED INSTEAD. 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 78 YR Required Intervention