BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2673575 · Received July 30, 2012

    Report

    Report Number
    3004209178-2012-06197
    Event Type
    Injury
    Date Received
    July 30, 2012
    Report Date
    June 29, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-45, LOT# V836553, IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE, LEAD PRODUCT ID 3888-45, LOT# V780541, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3888-33, LOT# V238362, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON 2012-(B)(6) THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) SHOWED HIGH IMPEDANCES ON THREE ELECTRODES. THE PATIENT ALSO EXPERIENCED A SHOCKING SENSATION. THE LEAD APPEARED TO BE FRACTURED AT THE PROXIMAL END AND WAS REPLACED. AFTER REPLACEMENT, THE PATIENT RECEIVED NORMAL THERAPEUTIC EFFECT. ADDITIONAL INFORMATION WAS RECEIVED ON 2012-(B)(6) THAT REPORTED THE PATIENT'S PROGRAMMER INCORRECTLY STATED THE PATIENT'S POSTURE WHEN USING THE ADAPTIVE STIMULATION FEATURE. THE PATIENT WAS GOING TO CONTACT THE MANUFACTURER'S REPRESENTATIVE FOR PROGRAMMING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention