BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4163349 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12362
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 23, 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
    IL, 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 PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. ANALYSIS REVEALED THAT THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. CONCOMITANT MEDICAL PRODUCTS: A 407652 LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) AND THAT DURING THE DEVICE CHANGE OUT PROCEDURE THE PHYSICIAN NOTICED THAT BOTH LEADS HAD BEEN ¿TWIDDLED¿. THE PHYSICIAN UNTWINED THE LEADS. IT WAS NOTED THAT THE ATRIAL LEAD¿S IMPEDANCE HAD INCREASED AND THAT THE RIGHT VENTRICULAR (RV) LEAD¿S IMPEDANCE HAS HAD A SLOW INCREASE OVER THE PAST TWO YEARS. BOTH LEADS WERE TESTED AND REVEALED NO NOISE OR IMPEDANCE SPIKES, THEREFORE THE PHYSICIAN ELECTED TO LEAVE THE LEADS IMPLANTED AND TO DISCUSS WITH THE PATIENT AT A LATER TIME. IT WAS THEN FURTHER REPORTED THAT THE RV LEAD HAD A POSSIBLE FRACTURE AND HAD HIGH IMPEDANCE. IT WAS NOTED AGAIN THAT THE RV LEAD HAD BEEN TWISTED IN THE POCKET FROM TWIDDLER¿S SYNDROME. THE RV LEAD WAS EXPLANTED AND REPLACED. THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644123 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization| R D154ATG ICD