BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2131923 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03544
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 A POWER ON RESET OCCURRED ON (B)(6) 2010. THE PATIENT IS CURRENTLY RECEIVING RADIATION TREATMENT TO THE RIGHT BREAST AND THE DEVICE IS IN THE LEFT PECTORAL AREA. RESET TOOK DEVICE TO VVI65 AND "WIPED OUT" IMPLANT DATE, DOCTOR AND LEAD INFORMATION. TWO PARITY ERRORS OCCURRED ON (B)(6) 2010 AND (B)(6) 2010 AT MEMORY ADDRESSES 36F9 & 3EA2. THE TWO PARITY ERRORS CAUSED INVALID DATA IN THE PATIENT INFORMATION AREA AND THE PROGRAMMER FORCED AN UPDATE TO GET RID OF THE ILLEGAL DATA. THE PACING MODE HAS BEEN PROGRAMMED FROM VVI TO MVP, BUT THE LOWER RATE INTERVAL IS STILL 920 MS (65 BPM). THE DEVICE REMAINS 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 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 5076 IMPLANTABLE PACING LEAD