BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 1802870 · Received August 17, 2010

    Report

    Report Number
    6000144-2010-04187
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    May 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SUMMARY: (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    A DEVICE WAS RETURNED WHICH APPEARED TO BE AN IMPLANT ATTEMPT DEVICE. NO SPECIFIC COMPLAINT WAS MADE AGAINST THE DEVICE. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION. 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 DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention 4068 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD| 6932 IMPLANTABLE TACHY LEAD