BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2890529 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-12379
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 6, 2012
    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

    PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3550-29 LOT# N250558, IMPLANTED: 2010 (B)(6), PRODUCT TYPE ACCESSORY (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE TELEMETRY ISSUES. IT WAS ALSO NOTED, THE PATIENT HAD NOT CHARGED FOR A FEW YEARS SUE TO LEAD MIGRATION WHICH HAPPENED SHORTLY AFTER IMPLANT. IT WAS UNKNOWN HOW MUCH BATTERY DAMAGE HAD OCCURRED. IT WAS ALSO NOTED, THE PATIENT WOULD HAVE A REVISION ON (B)(6) 2012 TO CORRECT THE MIGRATED LEAD. IT WAS NOTED THEY COULD NOT COMMENT ON WHETHER THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS DAMAGED ENOUGH TO REPLACE. FOLLOW UP REPORTED, THE PATIENT WAS SCHEDULED FOR A NEW LEAD AND INS ON (B)(6) 2012. AFTER THE POWER ON RESET (POR) THE PATIENT'S BATTERY WOULD NOT HOLD A CHARGE EVEN AFTER THREE CHARGES. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DOING 'FINE' AND HAD THERAPY 'WHERE THEY NEEDED IT' AFTER THE REPLACEMENT PROCEDURE. IT WAS NOTED THAT THERE WAS 'NOTHING WRONG' WITH THE DEVICE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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