BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2965146 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01619
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 23, 2012
    Report Date
    February 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE HELIX WAS DISTORTED/BENT, AND THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT.

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED SENSING DIFFICULTY. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD, BUT AFTER OVER 20 TURNS, THE HELIX WOULD NOT RETRACT. THE LEAD WAS EXPLANTED BY MANUALLY TURNING THE LEAD BODY. UPON REMOVAL OF THE LEAD, THE HELIX WAS TESTED, AND 35 TURNS WERE REQUIRED TO RETRACT THE HELIX, WHILE ONLY THREE WERE NEEDED TO EXTEND IT. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED SENSING DIFFICULTY. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD, BUT AFTER OVER 20 TURNS, THE HELIX WOULD NOT RETRACT. THE LEAD WAS EXPLANTED BY MANUALLY TURNING THE LEAD BODY. UPON REMOVAL OF THE LEAD, THE HELIX WAS TESTED, AND 35 TURNS WERE REQUIRED TO RETRACT THE HELIX, WHILE ONLY THREE WERE NEEDED TO EXTEND IT. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66651 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M72

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R