BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUIS DR

    MDR report key: 1792444 · Received August 11, 2010

    Report

    Report Number
    2647346-2010-00366
    Event Type
    Injury
    Date Received
    August 11, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S23
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    IT WAS REPORTED THE PATIENT HAS EXPERIENCED "TINGLING" IN THE AREA OF DEVICE AND A LOW BATTERY WAS IDENTIFIED AT DEVICE CHECK. MDT FOLLOW-UP INDICATES THAT DEVICE IS APPROACHING ERI AND PATIENT IS SCHEDULED FOR REPLACEMENT IN EARLY (B)(6). NO OTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7274 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD