BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3991031 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08350
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS AND WAS ANALYZED. THE INNER AND OUTER INSULATION OF THE LEAD WERE BOTH EXTRINSICALLY BREACHED DUE TO A CUT, AND THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. CONCOMITANT PRODUCT: 5076 LEAD, IMPLANTED: (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE RE PLACEMENT PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY IN ENGAGING THE SETSCREW ON THE DEVICE, AND EVENTUALLY REMOVED THE GROMMET IN ORDER TO ACCESS THE SETSCREW. THE PHYSICIAN THEN DECIDED TO EXPLANTED AND REPLACE THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469190 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R DDBB1D4 ICD