BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3152734 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06684
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT. IT WAS NOTED THAT THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE HELIX BENT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE ATTEMPTED RIGHT VENTRICULAR (RV) LEAD HAD DIFFICULTY TO EXTRACT THE HELIX WITH GREATER THAN OR EQUAL TO 22 ROTATIONS. DURING ANALYZER MEASUREMENTS A X-RAY SHOWED THE LEAD DISLODGED. ALSO THE ANALYZER MEASUREMENTS RESULTED IN HIGH IMPEDANCES AROUND 2500 OHMS. THE RV LEAD WAS REMOVED AND WHEN THE HELIX MECHANISM WAS TESTED EX-VIVO IT WAS NOT POSSIBLE TO EXTRACT THE HELIX OF THE LEAD. IT WAS NOTED THAT THE HELIX MECHANISM HAD BEEN SUCCESSFULLY TESTED PRIOR TO IMPLANT. THE RV LEAD WAS NOT IMPLANTED AND A DIFFERENT LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253240 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M72

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR