BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 3863298 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01342
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    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. CONCOMITANT MEDICAL PRODUCTS: A 5086MRI52 LEAD: IMPLANTED: (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A PARTIAL ELECTRICAL RESET. CRITICAL RAM PARITY ERROR OCCURRED IN ADDRESS 17 14 ON (B)(6) 2014. POWER ON RESET (POR) SEVERITY IS LOW SO THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED A PARTIAL DEVICE RESET. THE RESET WAS CLEARED AND THE DEVICE REMAINS 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
    338935 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP IPG MFG SWITZERLAND RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention 5086MRI58 LEAD