BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3355986 · Received September 18, 2013

    Report

    Report Number
    3004209178-2013-16546
    Event Type
    Injury
    Date Received
    September 18, 2013
    Report Date
    August 27, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 377745, LOT# V011262, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 377745, LOT# V011262, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONTRACTED (B)(6), THE DEVICE WAS REMOVED ABOUT THREE DAYS POST-IMPLANT, AND IT HAD NEVER BEEN TURNED ON. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469951 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 00047 YR Required Intervention