BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3072942 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06758
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID NEU_SILICONEANCHOR. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (LOT# VA0790G014) FOUND NO ANOMALY. ANALYSIS OF THE SILICONE ANCHOR 1 FOUND NO ANOMALY. ANALYSIS OF THE SILICONE ANCHOR 2 FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174364 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR