BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2910940 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00474
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE AS REMOVED DUE TO AN INFECTION. FOLLOW UP REPORTED PATIENT SYMPTOMS INCLUDED FEVER AND INFECTION. THE INFECTION WAS CONFIRMED BY A CULTURE. THE PATIENT RECOVERED WITHOUT SEQUELA. IT WAS NOTED THE DEVICE WAS EXPLANTED AND THROWN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16994 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