BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3120659 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07921
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 22, 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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377875 LOT# V003909, PRODUCT TYPE LEAD PRODUCT ID 377875 LOT# V003909, PRODUCT TYPE LEAD PRODUCT ID 377875 LOT# V003909, PRODUCT TYPE LEAD PRODUCT ID 377875 LOT# V003909, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER REPORTED THAT THE CAUSE OF THE EVENT WAS ¿INTERROGATION¿ AND THE EVENT WAS ATTRIBUTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE LEAD. IT WAS NOTED THAT THE REVISION WAS PENDING. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION AS A RESULT OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE LEAD IMPEDANCES WERE ALL GREATER THAN 40,000 OHMS INTRAOPERATIVELY AND THEY WERE UNABLE TO ACTIVATE THE STIMULATION. IT WAS NOTED THE PATIENT WAS BEING CONSULTED FOR A PADDLE LEAD SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222236 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 00041 YR