BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3062700 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06415
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 399930, LOT# J0444426V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE "DIDN'T SEEM TO BE FUNCTIONING CORRECTLY AT THE END OF THE WEEK." IT WAS NOTED THAT THE PATIENT RECHARGED HIS IMPLANTABLE NEUROSTIMULATOR (INS) ONCE A WEEK AND THERE WAS USUALLY 25% OF THE BATTERY REMAINING. STARTING A COUPLE MONTHS PRIOR TO THE REPORT, THE PATIENT'S BATTERY WAS 75% FULL BEFORE RECHARGING. IT WAS NOTED THAT THE PATIENT HAD NOT CHANGED HIS SETTINGS IN OVER A YEAR AND THE PATIENT NEVER TURNED HIS STIMULATION OFF. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS NOTED THAT AT THE END OF THE WEEK THEIR DEVICE DIDN'T SEEM TO HAVE THE SAME EFFECT THAT IT DID EARLIER ON. IT WAS NOTED THAT AFTER RECHARGING THE DEVICE FELT NORMAL; LIKE IT FELT AT THE BEGINNING OF THE WEEK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HIS DEVICE OR THERAPY, AND WAS TRYING TO WORK WITH HIS DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166190 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