BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4160113 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12008
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 14, 2014
    Report Date
    April 25, 2018
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    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 PRODUCT: 5076-52 LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING NOISE, NO CAPTURE, UNDERSENSING OF R-WAVES AND HIGH IMPEDANCE DUE TO FRACTURE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL, WHICH REMAINED IN USE AT THE TIME OF LEAD REVISION, APPEARED TO HAVE FRACTURED AS IT WAS EXHIBITING UNDEFINED IMPEDANCE. A SUDDEN INCREASE IN AND INSTABILITY OF SVC IMPEDANCE WERE ALSO REPORTED. THE PHYSICIAN PLANNED TO TURN THE SVC COIL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638920 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R D154ATG ICD