BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2811971 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16154
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 19, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 ANALYZED. NO ANOMALIES WERE FOUND. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. THE CONNECTOR PIN WAS BROKEN. VISUAL ANALYSIS NOTED THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-IMPLANT, THE LEAD HAD SIGNIFICANT DISTORTION OF THE DISTAL 10 CM OF THE LEAD. THE HELIX WAS UNABLE TO BE EXTENDED AFTER OVER 30 TURNS. THE LEAD WAS NOT USED FOR THE PROCEDURE. A SECOND LEAD WAS EXERCISED PRE-IMPLANT, BUT EVEN AFTER 40 TURNS WERE APPLIED, THE HELIX DID NOT DEPLOY. THE LEAD WAS NOTED WITH VERY SIGNIFICANT DISTORTION AT THE TIP WITHOUT ANY HELIX. THE SECOND LEAD WAS NOT USE FOR THE PROCEDURE. A NEW LEAD WAS USED FOR IMPLANT. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935M

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other