BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3993033 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09532
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 5076-52, LEAD, IMPLANTED: (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. NO ANOMALIES WERE FOUND. THE EXPOSED SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL BECAME EXTRINSICALLY FRACTURED DUE TO A CUT. THE INNER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. VISUAL ANALYSIS INDICATES APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE WAS TRENDING LOW. THE LEAD WAS EXTRACTED AND A NEW LEAD WAS IMPLANTED. DURING THE RV LEAD EXTRACTION PROCEDURE, THE LEAD WAS ENTANGLED WITH THE RIGHT ATRIAL (RA) LEAD AND CAUSED THE RA LEAD TO DISLODGE. THE PHYSICIAN WAS UNABLE TO REPOSITION THE LEAD SO THE LEAD WAS EXTRACTED AND A NEW RA LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468474 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R 7272 ICD