BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2822666 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-09998
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4): THE INS IS FUNCTIONALLY OKAY. FLUID OBSERVED BETWEEN THE CONNECTOR COVER AND THE SILICONE RUBBER INSIDE THE COVER IS COSMETIC ONLY AND DOES NOT IMPACT DEVICE PERFORMANCE. PRODUCT ID, 399945 LOT# V866962, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 399945 LOT# V866962, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 399945 LOT# V866962, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4). ANALYSIS OF THE DEVICE, SERIAL # (B)(4), FOUND THE DEVICE WAS FUNCTIONALLY OKAY. FLUID OBSERVED BETWEEN THE CONNECTOR COVER AND THE SILICONE RUBBER INSIDE THE COVER WAS COSMETIC ONLY AND DOES NOT IMPACT DEVICE PERFORMANCE. NO ANOMALY FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING GENERATOR SITE PAIN WITH MOVEMENT. IT WAS ALSO NOTED THAT THERE WAS "SEAL DISCOLORATION." THE DEVICE WAS EXPLANTED AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention