BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3992699 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09719
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    November 1, 2018
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    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. CONCOMITANT: DDBC3D1 ICD IMPLANTED: 2014-(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD ALERT TRIGGERED FOR LOW IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THE ALERT TRIGGERED AGAIN TWO WEEKS LATER. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE R WAVES WERE LOW.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR LOW PACING IMPEDANCE. IT WAS NOTED THIS IS A KNOWN ISSUE AND THE CLINIC IS MONITORING.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORT ED THE LEAD IS SCHEDULED TO BE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS OVERSENSING/SHORT V-V INTERVALS. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470351 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R