BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3002294 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03652
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES WERE TESTED POST-OPERATIVELY AND ELECTRODES 8-15 MEASURED >10000 OHMS. IT WAS STATED THAT THE IMPEDANCES WERE WITHIN THE NORMAL RANGE WHEN CHECKED INTRA-OPERATIVELY. IT WAS NOTED THAT THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM. IT WAS STATED THAT THE PHYSICIAN "DISCONNECTED THE SINGLE LEAD TAIL THAT HAD THE HIGH IMPEDANCES, WIPED IT DOWN, AND RESET THE IMPLANTABLE NEUROSTIMULATOR (INS)." IT WAS NOTED THAT THIS RESOLVED THE HIGH IMPEDANCES ISSUE. IT WAS STATED THAT THE PATIENT REPORTED HE WAS GETTING STIMULATION POST-OPERATIVELY AND THAT THE ISSUE WAS "COMPLETELY RESOLVED." IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105927 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention