BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3152085 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05542
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED TO THE MANUFACTURER. THE PRIMARY ANALYSIS FINDINGS REVEAL NO ANOMALIES. IT W AS ALSO NOTED THAT THE LEAD HAD APPARENT EXPLANT DAMAGE. PRODUCT: 4076 IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPLACEMENT FOR NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) THE RIGHT VENTRICULAR (RV) LEAD HAD VISIBLE DAMAGE TO THE LEAD INSULATION. IT WAS NOTED THAT THE RV LEAD MEASUREMENTS WERE ALL WITHIN NORMAL RANGE. THE RV 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
    252906 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R 7278 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR