BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 7742735 · Received August 2, 2018

    Report

    Report Number
    3007566237-2018-02288
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3487A-33 PRODUCT TYPE LEAD PRODUCT ID 3487A-33 PRODUCT TYPE LEAD PRODUCT ID 3487A-33 LOT# V012126 IMPLANTED: (B)(6)2006 PRODUCT TYPE LEAD PRODUCT ID 3487A-33 LOT# V012126 IMPLANTED: (B)(6)2006 PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED THAT THE INS WAS ERODING AND THEY REMOVED IT, WAITED SIX WEEKS AND WILL BE PLACING THE LATEST INS MODEL TODAY. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT'S NEW INS WAS NOT PLACED DUE TO LEAD MIGRATION. THE PATIENT IS BEING REFERRED TO A NEUROSURGEON FOR REMOVAL OF OLD LEADS AND REPLACEMENT WITH A PADDLE LEAD AND NEW GENERATOR. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583706 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention