BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2203679 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12366
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST ALSO NOTED THAT THE EXPOSED RV DEFIBRILLATION CONDUCTOR COILS WAS DAMAGED AT 51.2 CM AT IMPLANT. THE INTRODUCER TEST PASSED.

    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

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE A RIGHT VENTRICULAR LEAD WAS ATTEMPTED, BUT WAS DAMAGED AS THE PHYSICIAN ATTEMPTED TO ADVANCE AND REMOVE IT FROM THE INTRODUCER SHEATH. THE LEAD WAS REMOVED AND A NEW 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other 5076 X2 IMPLANTABLE PACING LEADS| 6949 IMPLANTABLE TACHY LEAD| 4968 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 X2 IMPLANTABLE PACING LEADS| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4968 IMPLANTABLE PACING LEAD