BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3634736 · Received February 19, 2014

    Report

    Report Number
    3004209178-2014-03265
    Event Type
    Injury
    Date Received
    February 19, 2014
    Report Date
    January 27, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377860, LOT# V001918, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7427, SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3888-28, LOT# J0301091V, IMPLANTED: 2003 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3550-09, LOT# LB1880, IMPLANTED: 2003 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT X-RAYS WERE TAKEN WHICH SHOWED THAT THE LEAD HAD MIGRATED FROM THE TIP AT T8 TO THE TIP AT T6. THE PATIENT HAD SEVERE PAIN IN HER MID TO UPPER BACK WHEN THE LEAD WAS TURNED ON. IT WAS NOT POSSIBLE TO USE THE LEAD FOR THE ¿ORIGINAL PURPOSE¿ TO HELP WITH LOW BACK PAIN. THE PATIENT WAS ALSO EXPERIENCING LESS THAN 50% THERAPY RELIEF. REPROGRAMMING WAS DONE BUT IT WAS UNCLEAR WHAT THE RESULT OF THAT WAS. A LEAD REVISION WAS PLANNED BUT NOT SCHEDULED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT WAS REPROGRAMMED AND UNDERWENT X-RAYS AND IMPEDANCE TESTING. IT WAS STATED THE PATIENT HAD EXPERIENCED A LOSS OF STIMULATION/THERAPEUTIC EFFECT AND THE LEAD HAD MIGRATED. IT WAS FURTHER STATED THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF AND PAIN AT THE LEAD LOCATION. IT WAS NOTED THE LEAD WOULD BE REPLACED IN THE FUTURE AND THE PHYSICIAN ¿PLANNED TO REVISE THE LEADS WHEN APPROVAL WAS RECEIVED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105282 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