BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 5501287 · Received March 15, 2016

    Report

    Report Number
    3004209178-2016-04598
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Report Date
    September 24, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 8590-8, LOT# N210800, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 8590-8, LOT# N206781, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4). ANALYSIS OF THE DESKTOP CHARGER C0277315 FOUND THE CONNECTOR PIN BROKEN. PLEASE REFERNECE MANUFATURER'S REPORT # 3004209178-20 REGARDING THE PATIENT'S OTHER INS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN, DEGENERATIVE DISC DISEASE AND CERVICAL RADICULOPATHY. IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WAS NOT CHARGING. IT WAS NOTED THE CONNECTOR PIN BROKE OFF THE PATIENT¿S RECHARGER. THE ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE. THE PATIENT¿S DEVICE WAS DISCHARGED BUT NOT OVERDISCHARGED AND THE MANUFACTURER¿S REPRESENTATIVE (REP) WAS ABLE TO INITIATE RECHARGING ON BOTH IMPLANTABLE NEUROSTIMULATOR (INS) BATTERIES. THE PATIENT HAD INCREASED PAIN DUE TO THE STIMULATORS NOT WORKING FOR THE LAST TWO TO FOUR WEEKS PRIOR TO THE REPORT. THE PATIENT LAST FELT STIMULATION ABOUT SEVEN TO 10 DAYS PRIOR TO THE REPORT. AFTER THE PATIENT RECEIVED HER NEW DESKTOP CHARGER SHE WAS ABLE TO FULLY RECHARGE BOTH OF HER INS¿S AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156746 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR