BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3759397 · Received April 18, 2014

    Report

    Report Number
    3004209178-2014-07513
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    April 2, 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
    GA, 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: 2013-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID NE U_PTM_PROG, PRODUCT TYPE PROGRAMMER, PATIENT, PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PATIENT¿S IMPLANT SURGERY THE LEAD WIRES SLIPPED AND THE SURGEON HAD TO GO BACK IN AND REVISE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238357 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 00068 YR Required Intervention