BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3142589 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08539
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752 LOT# V245999 SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3487A-45 LOT# V188696, IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37082-20 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37752 LOT# V245999 SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS IN ¿A LOT OF PAIN.¿ IT WAS NOTED RECENTLY, THE PATIENT HAD A BONE SCAN AND IT WAS DETERMINED THE PATIENT WOULD NEED AN INJECTION. IT WAS NOT NOTED WHAT TYPE OF INJECTION. IT WAS REPORTED THERE WAS NOTHING WRONG WITH THE DEVICE IT JUST DIDN¿T GET THE PATIENT THE RELIEF THEY THOUGHT IT WOULD. IT WAS NOTED THEY HAD DECIDED TO REMOVE THE STIMULATOR AND THEY HAD SCHEDULED A PAIN PUMP PLACEMENT. FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THE CAUSE OF THE EVENT WAS TOLERANCE TO STIMULATION. GOOD PARAESTHESIA COVERAGE BUT NO ANALGESIA. THERE WERE NO ABNORMAL IMPEDANCES NOTED. THE TRIAL OF ¿IOOS¿ WAS SUCCESSFUL. IT WAS NOTED THERE WAS NO CHANGE ON IMPLANTED PUMP AND MICRODOSING OF MORPHINE. THE ENTIRE SYSTEM WAS EXPLANTED. IT WAS NOTED THEY HAD BEEN UNSUCCESSFUL IN BEING ABLE TO REPROGRAM THE PATIENT AND ACHIEVE PAIN RELIEF. THE PATIENT DID REQUIRE HOSPITALIZATION DUE TO THE EVENT. IT WAS NOTED THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245231 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 Hospitalization