BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4160884 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11720
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    March 19, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 AND ANALYZED; ANALYSIS REVEALED THE OUTER INSULATION WAS BREACHED BY BI-/MULTI-LUMEN TUBING VOIDS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD OCCASIONAL NOISE NOTED ON THE STORED ELECTROGRAM (EGM) AND A SLIGHT INCREASE IN BOTH IMPEDANCE AND THRESHOLD WAS NOTED DURING THE PREVIOUS MONTH. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. IT WAS LATER REPORTED THAT THE RA LEAD HAD OVERSENSING NOTED ON REAL-TIME TELEMETRY AND ON ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. THE RA LEAD WAS EXPLANTED AND REPLACED. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD HAD LOW PACING IMPEDANCE AND OVERSENSING; A LEAD INTEGRITY ALERT WAS TRIGGERED. THE RV 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
    642557 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R D224DRG ICD, 5076-45 LEAD