BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT DR

    MDR report key: 3861487 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11197
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED A DAMAGED GROMMET AND THE SET SCREW WAS FOUND IN THE CONNECTOR BORE.

    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 THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ATTEMPTED, NOT IMPLANTED. AFTER THE PHYSICIAN CONNECTED THE LEAD TO THE DEVICE, THEY WERE UNABLE TO GET RIGHT VENTRICULAR (RV) IMPEDANCE. THE PHYSICIAN LOOSENED THE SET SCREW TO REMOVE THE LEAD, CHECKED THE PIN AND REINSERTED, BUT COULD NOT GET LEAD ALL THE WAY IN AND COULD NOT TURN THE SET SCREW AFTER MULTIPLE ATTEMPTS. A NEW DEVICE WAS IMPLANTED AND 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
    343007 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR