BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2955356 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02092
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION WAS RECEIVED FROM THE CLINIC WHICH INDICATED THE DEVICE HISTORY HAD BEEN CHECKED AND THE PATIENT HAD RECEIVED THREE APPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. ALSO THAT THERE WAS NO INDICATION IN THE RECORDS OF THE DEVICE BEEPING AND IT WAS THOUGHT THE DEVICE WAS FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEIR DEVICE WAS BEEPING, AND THE PATIENT QUESTIONED IF IT COULD BE DUE TO THE DEVICE BATTERY. THE PATIENT ALSO REPORTED THEY HAD BEEN HOSPITALIZED BECAUSE THE DEVICE WENT OFF TWICE. THE DEVICE IS STILL 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
    59669 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| L 69345 IMPLANTABLE TACHY LEAD