BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3991666 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08008
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THIS LEAD WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. CONCOMITANT MEDICAL PRODUCTS: 5568-53 LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING AND NOISE AND WAS FIRST NOTED DURING THE PATIENT¿S OFFICE VISIT. THE NOISE AND OVERSENSING WAS PRODUCIBLE WITH POCKET MANIPULATION. THE LEAD ALSO HAD HIGH IMPEDANCE AND WAS SUSPECTED OF A POSSIBLE FRACTURE. THE PATIENT WAS SCHEDULED FOR A LEAD REPOSITION PROCEDURE. DURING THE REPOSITIONING PROCEDURE NOISE AND OVERSENSING WAS NOTED AND THE PHYSICIAN WAS UNABLE TO RETRACT THE HELIX OF THE LEAD. SUBSEQUENTLY THE RV LEAD WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468324 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R D274DRG ICD