BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2202092 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03870
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY AFTER IMPLANT, THE PATIENT BEGAN EXPERIENCING DIAPHRAGMATIC STIMULATION RESULTING IN SEVERE CONVULSIONS. AT FIRST THIS WAS THOUGHT TO BE TIED TO PACER OUTPUT, BUT THE PHYSICIAN STATED THAT IT WAS NOT. TESTING WAS PERFORMED IN DIFFERENT POSITIONS WITH NO CHANGE TO PATIENT SYMPTOMS. A CHEST X-RAY WAS UNREMARKABLE. DURING THE EXPLANT PROCEDURE, WHEN THE DEVICE WAS REMOVED FROM THE POCKET, THE SYMPTOMS STOPPED, BUT WHEN THE DEVICE WAS PLACED ON THE SKIN, THE SYMPTOMS RETURNED. THE DEVICE WAS EXPLANTED AND REPLACED. 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 MED REL, INC. RVDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R (B)(4) X2 IMPLANTABLE PACING LEAD