BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT DR

    MDR report key: 3151645 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-08825
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 15, 2013
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE DEVICE AND LEAD WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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 THAT DURING DEVICE FOLLOW-UP IT WAS FOUND THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY AND A LEAD INTEGRITY ALERT TRIGGERED DUE TO THE RIGHT VENTRICULAR (RV) LEAD HAVING OVERSENSING AND NOISE. AN X-RAY WAS ORDERED TO ENSURE OVERSENSING OF 6949 WAS NOT DUE TO SETSCREW ISSUE. THE DEVICE AND RV LEAD REMAIN 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
    252382 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Hospitalization| L| R 6949 IMPLANTABLE TACHY LEAD