BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3833435 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09638
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 6, 2014
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3986A, LOT# N102726, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3986A, LOT# N092341,IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LAST RECHARGE WAS ¿ABOUT¿ THREE WEEKS PRIOR TO REPORT. THE PATIENT WAS NOT SURE IF THE STIMULATION WAS ON OR NOT AND THEY ¿SOMETIMES FELT IT SOMETIMES THEY DID NOT.¿ THE PATIENT ALSO NOTED THAT SINCE IMPLANT THEY STILL HAD CHRONIC PAIN AND TOOK MEDICATION. THE CALLER STATED THAT THEY HAD CONSTANT PAIN AND SO WAS NOT SURE IF THEY FELT NORMAL PAIN OR IF IT WAS PAIN FROM STIMULATION BEING OFF. THE CALLER STATED THAT THEY USUALLY SAW THE MANUFACTURER REPRESENTATIVE IN THE HEALTHCARE PROFESSIONAL¿S (HCP) OFFICE. THE PATIENT STATED THAT THEY HAD ATTEMPTED TO CONTACT THE MANUFACTURER REPRESENTATIVE BUT HAD NOT HEARD A RESPONSE. THE PATIENT ALSO NOTED THAT THEY HAD LOST THE RECHARGER AND PATIENT PROGRAMMER DURING A TRIP. THE PATIENT ALSO MENTIONED THAT THEY HAD A PREVIOUS IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED DUE TO NORMAL SERVICE LIFE. THE PATIENT WAS REDIRECTED TO THE HCP. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310978 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 00060 YR