BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2201627 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01334
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE ANALYST CHECKED THE RAW CODE AND NO PARITY OR POWER ON RESET (POR) EVENTS HAD BEEN RECORDED. ALSO NOTICED NO PATIENT ALERT ASSOCIATED WITH A POR WAS LOGGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION, THE DEVICE HAD NO BATTERY VOLTAGE APPEAR AS THE DEVICE WAS IN ELECTRICAL RESET. THE DEVICE WAS SEALED IN NON-OPENED BOX. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVO MRI SURESCAN IMPLANTABLE PULSE GENERATOR LWP MEDTRONIC S.A. RVDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other