BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2810669 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06041
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 THE PATIENT HAS BECOME SEPTIC. THE PHYSICIAN CONSIDERED REMOVING THE EXISTING DEVICE AND LEADS, BUT INSTEAD CUT THE CHRONIC ABANDONED COMPETITOR LEAD SYSTEM FOR THE TIME BEING. THE PATIENT WILL CONTINUE ANTIBIOTIC TREATMENT AND TEMPORARILY POSTPONE THE SYSTEM REMOVAL. NO FURTHER 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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R