BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4233352 · Received November 6, 2014

    Report

    Report Number
    3007566237-2014-03253
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3877-45, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S LEAD WAS REPLACED DUE TO HIGH IMPEDANCES ON (B)(6) 2014. IT WAS BELIEVED THAT THE LEAD WAS THE CAUSE OF THE HIGH IMPEDANCES BECAUSE THE LEAD WAS TESTED WITH THE MULTI-LEAD TRIALING CABLE AND THE LEAD WAS REPLACED. A SECOND LEAD WAS ALSO ADDED DURING THE REPLACEMENT SURGERY. THE EXISTING IMPLANTABLE NEUROSTIMULATOR (INS) WAS KEPT. SINCE THE REVISION, THE PATIENT EXPERIENCED A PAINFUL SENSATION AT THE POCKET SITE. THE PATIENT WAS ALSO NOT FEELING STIMULATION IN THE CORRECT LOCATION. IT WAS NOTED THAT IT WAS UNCLEAR IF THE PATIENT WAS NOT FEELING STIMULATION AT ALL, OR IF THE PATIENT FELT STIMULATION BUT IN THE INCORRECT LOCATION. IMPEDANCES MEASURED ON (B)(6) 2014 WERE WITHIN NORMAL LIMITS. THE LEADS WERE GOING TO BE IMAGED ON (B)(6) 2014. THE PATIENT OUTCOME WAS NOT KNOWN AT THE TIME OF THE REPORT. ADDITIONAL FOLLOW UP IS BEING PERFORMED AND A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY FOLLOWING THE LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712948 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention