BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3861211 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07354
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 4, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: 5076, LEAD, IMPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING ASSESSMENT AT DEVICE REPLACEMENT THE LEAD IMPEDANCE HAD AN ABNORMAL READING, THE PACING THRESHOLD HAD INCREASED, THERE WAS OVERSENSING OF ARTIFACT, AND FRACTURE WAS ELECTRICALLY CONFIRMED. THE PATIENT WAS ENROLLED IN THE SYSTEM LONGEVITY STUDY (SLS).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD AN APPARENT FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340731 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6943-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D164AWG ICD