BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3981881 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13994
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 14, 2014
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: RECHARGER; PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. IT WAS NOTED INCREASING STIMULATION DID NOT RESOLVE THE ISSUE. IT WAS REPORTED THE PATIENT DID NOT HAVE ADDITIONAL GROUPS TO TRY. IT WAS NOTED THE PATIENT WAS ENCOURAGED TO TURN DEVICE DOWN TO ZERO AND LEAVE OFF UNTIL APPOINTMENT. IT WAS REPORTED THE PATIENT HAD HIGH IMPEDANCES ON MULTIPLE ELECTRODES. IT WAS NOTED X-RAY SHOWED THE LEAD HAD MIGRATED DOWN FROM T8 TO T9 WITH THE BOTTOM OF THE LEAD OUT OF THE EPIDURAL SPACE. IT WAS REPORTED THERE WAS NO TRAUMATIC EVENT ASSOCIATED WITH ISSUES. IT WAS NOTED THE PATIENT WAS CONSIDERING REMOVAL AND LEAD REVISION. IT WAS REPORTED THE DEVICE WAS DEPROGRAMMED AND TURNED OFF. IT WAS NOTED THE PATIENT COULD NOT BE REPROGRAMMED DUE TO LEAD POSITION. IT WAS REPORTED THE PATIENT WAS NOT INJURED. IT WAS NOTED THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS HAPPENING THE AFTERNOON OF 2014-(B)(6). THE EXPLANT WAS COMPLETE. IT WAS NOT KNOWN HOW THE PATIENT WAS DOING POST-EXPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAS OPTED TO NOT HAVE THE LEAD REPLACED BUT TO HAVE THE ENTIRE SYSTEM REMOVED AND IS MEETING WITH A NEW HEALTH CARE PROVIDER (HCP) TO SCHEDULE THE EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WHEN RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458588 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