BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3993956 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09039
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE HELIX OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLIN G/STRETCHING/OVERSTRESS, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN WAS HAVING DIFFICULTY GETTING THE LEAD TO CROSS THE VALVE. IT WAS NOTICED THE HELIX WAS DEPLOYED. THE PHYSICIAN RETRACTED THE SCREW MECHANISM AND THE BLOCK APPEARED TO RETRACT HOWEVER, THE SCREW APPEARED TO STILL BE DEPLOYED. THE LEAD WAS REMOVED AND UPON EXAMINATION OF THE LEAD IT APPEARED THE HELIX HAD STRETCHED. A DIFFERENT LEAD WAS EFFECTIVELY UTILIZED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470702 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR