BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA SR

    MDR report key: 1861797 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04832
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    PATIENT REPORTED FEELING A "PULSATING" INTERMITTENTLY IN SHOULDER AND ARM SINCE PACEMAKER REPLACEMENT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SESR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other IMD49B IMPLANTABLE PACING LEAD