BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 7379266 · Received March 28, 2018

    Report

    Report Number
    3004209178-2018-05949
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    January 1, 2018
    Report Date
    March 28, 2018
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-45, LOT# V800631, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V800631, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V809812, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3888-45, SERIAL/LOT #: V800631, UBD: (B)(6) 2015, UDI#: (B)(4); PRODUCT ID: 3888-45, SERIAL/LOT #: V809812, UBD: (B)(6) 2015, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) VIA A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR OTHER CHRONIC/INTRACTABLE PAIN IN THEIR TRUNK/LIMBS. THERE WAS AN OUT OF RANGE (OOR) IMPEDANCE ON THE SUBQ LEADS. THE PATIENT WAS NOT FEELING STIMULATION ON TWO OF THEIR LEADS. THEY HAD NO FALLS. THE PATIENT WAS NOT SURE WHEN THEY FIRST NOTICED IT NOT WORKING; WITHIN THE YEAR. THE REP DID AN IMPEDANCE CHECK AND ELECTRODES 2, 3, 5, 6, 11, AND 15 WERE ALL OVER 10,000 OHMS. THE REP REPROGRAMMED USING ¿GOOD¿ ELECTRODES AND WAS ABLE TO REGAIN STIMULATION IN THOSE AREAS ONCE AGAIN. THE REP NOTED THAT THE PATIENT HAS 4 QUAD LEADS PLACED SUBCUTANEOUSLY AND AT LEAST 1 ELECTRODE IS OUT ON EACH LEAD AND 2 OUT ON 2 OF THE LEADS. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT AND THE PATIENT WAS NOTED TO BE ALIVE WITH NO INJURY. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221244 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 41 YR