BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4178509 · Received October 16, 2014

    Report

    Report Number
    3004209178-2014-19829
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Report Date
    September 30, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V073596, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-41 LOT# V009886, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A ¿SUDDEN¿ LOSS OF STIMULATION OR THERAPEUTIC EFFECT AS WELL AS PAIN IN THE SACRAL AREA. DIAGNOSTIC TESTING WAS PERFORMED SUCH AS REPROGRAMMING AND IMPEDANCE TESTING. IMPEDANCE TESTING WAS NORMAL AND NO CAUSE WAS DETERMINED. THE PATIENT HAD A 50% OR GREATER SYMPTOM REDUCTION, AND WAS ¿DOING WELL AND RECEIVING EFFECTIVE THERAPY.¿ FOLLOW UP IS BEING CONDUCTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659182 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1