BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 6005131 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-11209
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 15, 2016
    Report Date
    July 18, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: 507135 LEAD, IMPLANTED: (B)(6) 2005. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. THE OVERLAY TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    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 PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO POSSIBLE T-WAVE OVERSENSING (TWOS) ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT PRESENTED TO THE CLINIC AFTER THEY HAD RECEIVED THE INAPPROPRIATE THERAPY AND DEMONSTRATED INCREASED AND HIGH THRESHOLDS ON THE RV LEAD AS WELL AS THE EPICARDIAL LEAD. WITH THIS, THEY DISCOVERED THAT THE PATIENT HAD TWIDDLER'S SYNDROME. A CHEST X-RAY CONFIRMED TANGLED AND ENTWINED LEADS IN THE POCKET. THE RV LEAD HAD CURLED AROUND ITSELF IN THE POCKET AND PHYSICIAN HAD TO UNRAVEL THE BENT LEAD. AS A RESULT OF THE TWIDDLING, THE RV LEAD HAD DISLODGED AS IT HAD BEEN PULLED BACK INTO THE ATRIUM AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)EXPERIENCED PREMATURE BATTERY DEPLETION CAUSED BY HIGH OUTPUTS NECESSITATED BY THE EPICARDIAL LEAD CAPTURE THRESHOLD INCREASE. THE PATIENT ALSO EXPERIENCED NERVE STIMULATION AS A RESULT. THE EPICARDIAL LEAD WAS CAPPED AND REPLACED AND THE RV LEAD AND DEVICE WERE EXPLANTED AND REPLACED. INSULATION DAMAGE OCCURRED ON THE RV LEAD DURING THE CHA NGE OUT PROCEDURE TO GAIN ACCESS TO THE SUBCLAVIAN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654094 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 507652 LEAD, DTBA1D4 ICD