BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA DR

    MDR report key: 3153631 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08927
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 PRODUCTS: 5076 IMPLANTABLE PACING LEAD - (B)(6) 2007, 5076 IMPLANTABLE PACING LEAD - (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED 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 DURING THE IMPLANT PROCEDURE, THE DEVICE EXHIBITED OVERSENSING AND AN OUTPUT FAILURE. THE DEVICE WAS DETERMINED TO EXHIBIT A SETSCREW ISSUE. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DEVICE EXHIBITED OVERSENSING AND AN OUTPUT FAILURE. THE DEVICE WAS DETERMINED TO EXHIBIT A SETSCREW ISSUE. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258841 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR 6949 IMPLANTABLE TACHY LEAD