BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 2964630 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02354
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT "THEY ARE FEELING LITTLE TINY SHOCKS, THEIR HEART BEATS FAST, AND IT'S LIKE A LITTLE A TINGLE AROUND THE DEVICE AND SOMETIMES AROUND THE LEAD. THEN IT'S LIKE A SHARP PAIN, GOES TO THE MIDDLE THEN TO THE SIDE. JUST STARTED DOING IT YESTERDAY, LIKE SHARP STABBING PAIN" THE PATIENT ALSO STATED THAT THEY WERE IN THE HOSPITAL MONDAY AND TUESDAY OF HIS WEEK BECAUSE OF HEART PALPITATIONS. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69234 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS D314VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 6949 DEFIB LEAD