BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3153416 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05999
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. INTERFERENCE/NOISE WAS NOTED, WITH VENTRICULAR SHORT INTERVAL COUNT V-SIC OF 1875 COUNTS, OCCURRING IN 46.81 DAYS BETWEEN (B)(6) 2012 AND (B)(6) 2013. CONCOMITANT PRODUCT: PRODUCT ID D284VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED TACHYCARDIA (NST) EPISODES ON THE RIGHT VENTRICULAR (RV) LEAD. INSULATION DAMAGE WAS SUSPECTED. THE LEAD WAS CUT, CAPPED 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
    256501 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 69436536

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R