BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3133542 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08308
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 7, 2013
    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
    TX, 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 3550-39, LOT# N337479, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A ¿REVISION¿ ON (B)(6) 2013 DUE TO THE LEAD MIGRATING TO THE SIDE. IT WAS STATED REPROGRAMMING WAS ATTEMPTED WITHOUT SUCCESS. IT WAS NOTED THAT THIS HAD BEEN GOING ON FOR THE PAST COUPLE MONTHS. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234810 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