BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 5712718 · Received June 9, 2016

    Report

    Report Number
    2182208-2016-01539
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    April 13, 2016
    Report Date
    April 20, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): 419478 LEAD, IMPLANTED: (B)(6) 2005-06-01. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON NOTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD BEEN REPAIRED. FOLLOW UP WITH THE PATIENT'S COULD NOT ASCERTAIN THE NATURE OF THE PROBLEM WHICH NECESSITATED INTERVENTION. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365214 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6943-65

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R