BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2990314 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03343
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 355531, LOT # N332908, IMPLANTED: (B)(6) 2012, PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT HAD A REPLACEMENT IMPLANTABLE NEUROSTIMULATOR (INS) PLACED IN A NEW POCKET, AN IMPEDANCE TEST FOUND HIGH IMPEDANCES. IMPEDANCES GREATER THAN 10,000 AND GREATER THAN 40,000 OHMS ON ELECTRODES 2, 3, 4, 7, 10, AND 11 USING 2 DIFFERENT CLINICIAN PROGRAMMERS. THE PATIENT WAS WOKEN UP DURING SURGERY TO TEST STIMULATION AND GOOD COVERAGE OF PAIN AREA WAS ACHIEVED. PATIENT STATUS AT TIME OF REPORT WAS NOTED AS NO INJURY AND NO ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SEEN ONCE FOLLOWING HER REPLACEMENT AND ACHIEVED ¿GOOD COVERAGE¿ AS WELL AS RE-ACTIVATION OF ADAPTIVE STIM. NO HIGH IMPEDANCES WERE SEEN AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93836 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 59 YR