BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA VR

    MDR report key: 1924030 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06073
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 22, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. EVALUATION: (B)(4) NO ANOMALIES WERE FOUND. THE SET SCREW WAS LOOSE. THE ANALYST COMMENTED THAT A TEST LEAD WAS FULLY INSERTED INTO ALL CONNECTOR PORTS. ALL SETSCREWS WERE TIGHTENED WITH A MEDTRONIC WRENCH AND ALL SET SCREWS RETAINED THEIR LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYSTEM UPGRADE THE "LEAD FAILED TO PLUG INTO THE HEADER" OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD WAS NOT IMPLANTED AND A NEW ICD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other