BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 6130086 · Received November 28, 2016

    Report

    Report Number
    3004209178-2016-24762
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    November 11, 2016
    Report Date
    January 27, 2017
    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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) REPORTED END OF SERVICE (EOS), THE DEVICE WAS OFF/DISABLED AND NO LONGER PROVIDING THERAPY. THE PATIENT MAY NOT REMEMBER PREVIOUS OVERDISCHARGE RECOVERIES BUT THEY KNEW THAT THERE WAS ONE ATTEMPTED THAT THEY HAD MADE THIS MONTH. IT WAS NOTED THAT THEY COMPLETED AN OVERDISCHARGE RECOVERY ON (B)(6) 2016 AND THE POWER ON RESET (POR) WAS CLEARED. THE PATIENT WAS TO FOLLOW-UP WITH AN HEALTH CARE PROFESSIONAL (HCP), IT WAS NOTED THAT THEY DID NOT CURRENTLY HAVE AN HEALTH CARE PROFESSIONAL (HCP). IT WAS NOTED THAT THE EOS WAS SEEN BY THE PATIENT ON (B)(6) 2016, A FEW DAYS AFTER THE (B)(6) APPOINTMENT. THE EOS WAS CONFIRMED BY THE REP ON (B)(6) 2016.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT AN OVERDISCHARGE WAS ALLEGED AND THE DEVICE WAS EXPLANTED. IT WAS NOTED THAT THE IMPLANT WASN¿T HOLDING A CHARGE AFTER GOING INTO OVERDISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780023 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 46 YR Required Intervention