BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 6036428 · Received October 18, 2016

    Report

    Report Number
    3004209178-2016-21966
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 18, 2016
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3888-56, LOT# V210855, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-56, LOT# V250886, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-56, LOT# V250886, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3888-56, LOT# V215937, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT REPORTED VIA MANUFACTURER REPRESENTATIVE TWO OCCASIONS IN WHICH THEY WERE RECENTLY SHOCKED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNPLEASANT STIMULATION WHEN THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SITE WAS PRESSED UPON. THE ISSUE WAS QUICKLY RE SOLVED BOTH TIMES. IT IS UNKNOWN IF ANY ENVIRONMENTAL OR EXTERNAL FACTORS MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. IMPEDANCE TESTS WERE RAN AND FOUND ELECTRODES 11, 12, AND 15 TO BE >10,000 OHMS. THE MANUFACTURER REPRESENTATIVE REMOVED THE AFFECTED ELECTRODES FROM THE PROGRAMMING OPTIONS AVAILABLE TO THE PATIENT. AFTERWARDS, OPTIMAL COVERAGE WAS ACHIEVED. THE PATIENT WAS TO NOTIFY THE MANUFACTURER REPRESENTATIVE OF ANY ISSUES IN THE FUTURE. INDICATIONS FOR USE ARE CERVICAL/NECK AND OCCIPITAL NEURALGIA. THE PATIENT'S STATUS AT THE TIME OF THIS REPORT IS "ALIVE, NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688214 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 54 YR