BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3153136 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08881
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 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
    IN, 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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE POST OPERATIVE DEVICE CHECK, THE PATIENT ALERT SOUNDED, AND THE ATRIAL LEAD EXHIBITED HIGH IMPEDANCES, NOISE, AND FAR FIELD R-WAVE (FFRW) OVERSENSING. THE POCKET WAS REOPENED, AND IT WAS DETERMINED THAT THE ATRIAL LEAD HAD NOT BEEN FULLY INSERTED INTO THE DEVICE HEADER. THE LEAD PIN WAS REINSERTED, AND SUBSEQUENT TESTING INDICATED THAT THE DEVICE AND LEAD WERE FUNCTIONING NORMALLY. THE DEVICE AND LEAD REMAIN 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
    255488 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R 6935M IMPLANTABLE TACHY LEAD