BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO DR

    MDR report key: 2202968 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04050
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POWER ON RESET. THE DEVICE WAS REPROGRAMMED AND IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7278 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD