BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO VR

    MDR report key: 1792433 · Received August 11, 2010

    Report

    Report Number
    6000094-2010-01481
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    May 5, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A TEN MINUTE EVENT WHERE THE NUMBER OF INTERVALS DETECTED (NID) WAS 30/40. THE PATIENT HAD VENTRICULAR FIBRILLATION (VF) ARREST AND RHYTHM WAS NOT SEEN BY THE DEVICE. THE NON SUSTAINED TACHYCARDIA (NST) AND EPISODES WERE RECORDED. THE R TIMES ON TELEMETRY STRIPS DO NOT CORRELATE WITH STORED EVENTS FROM DEVICE THAT ARE ON FAX. IT APPEARS AS AN EXTERNAL REGULAR HIGH AMPLITUDE SIGNAL IS COMPETING WITH THE INTRINSIC EVENTS CAUSING DOUBLE COUNTING. THE DEVICE IS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD