BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5204290 · Received November 5, 2015

    Report

    Report Number
    3004209178-2015-22266
    Event Type
    Injury
    Date Received
    November 5, 2015
    Report Date
    October 16, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-45, LOT# V121154, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT HAD SIGNIFICANT RELIEF FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) BUT AS TIME WENT FORWARD THEY FOUND IT OF LESS HELP AND DECIDED TO HAVE IT REMOVED. IT WAS NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND THEY RETURNED TO THE AMBULATORY PREP AREA IN GOOD CONDITION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED ON (B)(6) 2015 THAT THEY HAD A NEUROSTIMULATOR AND MAXED OUT THE CONTROLS BETWEEN (B)(6) OF 2008 AND (B)(6) 2009. THEIR HEALTH CARE PROVIDER (HCP) HAD REMOVED THE STIMULATOR SYSTEM IN 2009. THE RELATED MEDICAL HISTORY INCLUDED SPINAL PAIN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736185 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 00044 YR Required Intervention