BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2740811 · Received September 12, 2012

    Report

    Report Number
    3004209178-2012-08024
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Date of Event
    August 13, 2012
    Report Date
    August 23, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377845, LOT# V013536, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 377845, LOT# V013536, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT FEEL STIMULATION FROM THE LEFT LEAD DURING TESTING WITH A VARIETY OF CONTACT CONFIGURATIONS. IMPEDANCE MEASUREMENTS WERE TAKEN. IT WAS DISCOVERED THAT THE LEFT LEAD HAD HIGH IMPEDANCES, AND LEAD DAMAGE WAS SUSPECTED. THE LEAD WAS NOT REVISED OR REPLACED, BECAUSE THE PATIENT HAD "GOOD PAIN COVERAGE" WITH THE RIGHT LEAD. THERE WERE NO SYMPTOMS RELATED TO THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED IMPEDANCE MEASUREMENTS WERE GREATER THAN 20,000 OHMS. ALL COMBINATIONS WITH 0-7 WERE OUT OF RANGE. THE MANUFACTURER REPRESENTATIVE DID NOT WANT TO RUN DEFAULT TESTING HIGHER THAN 1.5 VOLTS. IMPEDANCES WITH ELECTRODES 8-15 WERE WITHIN NORMAL LIMITS. THE PATIENT WAS NOT PROGRAMMED ON THE 0-7 LEAD. THE THERAPY WAS INDICATED FOR RIGHT FOOT PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED. IT WAS ALSO REPORTED THAT NO INTERVENTIONS WERE TAKEN AND THE PATIENT'S OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR