BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3153355 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05953
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE PROXIMAL AND DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO MELTING. THE OVERLAY TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO MELTING AND THE OVERLAY TUBING OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED, HELIX WILL NOT EXTEND/RETRACT AT THIS TIME DUE TO THE DRIED BLOOD IN THE TIP END OF THE DISTAL CONDUCTOR PREVENTING TORQUE TRANSFER WHEN THE CONNECTOR PIN IS ROTATED. BLOOD COULD NOT BE REMOVED WITHOUT DAMAGING THE HELIX.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT: CD1257-40Q COMPETITOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2013.(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 HAD VARIABLE R-WAVES. IT WAS DETERMINED THAT THE LEAD WAS DISLODGED. THE LEAD WAS EXPLANTED 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
    258099 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R