BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3211124 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11445
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 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

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHECKED DURING PREPARATION AND THE RECHARGER INDICATED IT WAS 100% FULL. IT WAS NOTED THAT THEN LEAD CONFIGURATION COULD NOT BE SELECTED AND THE STATUS OF THE INS WAS ¿DISCHARGED AND X.¿IT WAS NOTED THAT ANOTHER INS WAS USED AND THE RECHARGER ALSO INDICATED IT WAS 100% FULL. THE INS WAS REREAD WITH THE CLINICIAN PROGRAMMER WHICH BROUGHT IT TO THE NORMAL INTRODUCTION SCREEN TO CHOOSE LEAD CONFIGURATION. IT WAS NOTED THE MANUFACTURING REPRESENTATIVE DID NOT WANT TO TRY IT ¿IN CASE IT WORKED THIS TIME¿ AND STARTED THE BATTERY LIFE. IT WAS NOTED THE REPRESENTATIVE ¿DID NOT TRUST THE BATTERY FOR FUTURE USE.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED, THE DEVICE WAS RETURNED FOR ANALYSIS. THE CAUSE WAS STILL UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310953 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