BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4936846 · Received July 23, 2015

    Report

    Report Number
    3004209178-2015-14031
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Report Date
    June 26, 2015
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377760, LOT# V002822, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V002680, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-56, LOT# V349340, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# V488650, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V003782, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS FOR THE 3888-56 LEAD REVEALED THAT THE 0, 1, AND 2 CONDUCTORS WERE BROKEN AT THE PROXIMAL END OF ELECTRODE 3. ELECTRODE 3 WAS BROKEN AT THE WELD SITE. FINAL DEVICE ANALYSIS FOR THE 3487A-56 LEAD REVEALED NO SIGNIFICANT ANOMALIES.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REPLACEMENT SURGERY DUE TO NORMAL BATTERY DEPLETION. A POSSIBLE REVISION WAS NOTED. IMPEDANCES WERE CHECKED PRIOR TO THE BATTERY CHANGE AND HIGH IMPEDANCES WERE FOUND IN QUAD (LEAD). FURTHER CLARIFIED THAT THE CERVICAL LEAD HAD HIGH IMPEDANCES OF GREATER THAN 3,600OHMS WITH ELECTRODES: 0, 1, 2, 3, AND 9. THE PATIENT HAD DIMINISHED STIMULATION OF THE AREA. THE LEADS WERE REPLACED. THE ISSUE WAS RESOLVED. THE HEALTH CARE PROVIDER (HCP) HAD NO FURTHER INFORMATION FOR THE DEVICE MANUFACTURER. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480762 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR