BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 6625245 · Received June 8, 2017

    Report

    Report Number
    2649622-2017-05618
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    March 21, 2017
    Report Date
    March 22, 2017
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS THE LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE OF THE SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. THE PARTIAL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND THE EXPOSED SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE SETSCREW MARKS ON THE CONNECTOR PIN WERE TOO PROXIMAL. CONCOMITANT MEDICAL PRODUCTS: DDMB1D1, ICD, IMPLANTED (B)(6) 2017.

    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'S RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED FOR HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL OF THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402992 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-58

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R