BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 5501270 · Received March 15, 2016

    Report

    Report Number
    3004209178-2016-04596
    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

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID :37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. 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: 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37761 SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(6). (B)(4). ANALYSIS OF THE DESKTOP CHARGER (B)(4) FOUND THAT THE CONNECTOR PINS WERE BROKEN.

    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
    158449 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