BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3316908 · Received August 29, 2013

    Report

    Report Number
    3004209178-2013-15411
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Report Date
    August 5, 2013
    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 355531, LOT# N324594, IMPLANTED: 2012-(B)(6), PRODUCT TYPE SCREENING, DEVICE PRODUCT ID 8591-38, LOT# D17878, IMPLANTED: 2012-(B)(6), PRODUCT TYPE ACCESSORY, PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TRIED TO CHARGE AND IT WOULD NOT CHARGE. IT WAS NOTED THAT THE PATIENT HAD BEEN UNABLE TO CHARGE FOR TWO WEEKS PRIOR TO THIS REPORT AND THE PATIENT WAS NORMALLY CHARGING ONCE A WEEK. THE LAST TIME THE PATIENT FELT STIMULATION WAS ON 2013-(B)(6). THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WAS SHOWING THAT THE PATIENT NEEDED TO REPOSITION THE ANTENNA AND CHARGE. IT WAS LATER REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. THERE WAS AN UNCONFIRMED FLIPPED DEVICE. AN X-RAY WAS TAKEN TO SEE IF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS FLIPPED. THE PATIENT WAS UNABLE TO COMMUNICATE WITH THE INS USING THE PATIENT PROGRAMMER, INSR OR CLINICIAN PROGRAMMER. SYMPTOMS ASSOCIATED WITH THIS EVENT WERE LESS THAN 50% THERAPY RELIEF AT THE DEVICE POCKET. THE PATIENT HAD HAD THE IMPLANT FOR 1.5 YEARS. IT WAS LATER REPORTED THAT THERE WAS A COMMUNICATION PROBLEM. IT WAS NOTED THAT THE INS MAY BE FLIPPED. IT WAS NOTED THAT THE PROBLEM HAD STARTED SOMETIME A WEEK PRIOR TO 2013-(B)(6). NEITHER AN ANTENNA LOCATE FEATURE NOR PHYSICIAN MODE RECHARGE HAD BEEN TRIED WITH THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE LAST TIME THE PATIENT HAD BEEN SEEN WAS POST IMPLANT ON 2012-(B)(6). PATIENT HAD BEEN SURGICALLY RELEASED TO PAIN MANAGEMENT. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    AS OF (B)(6) 2013 THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR COMPANY REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT IT WAS SUSPECTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS FLIPPED BUT WHEN THE PATIENT MET WITH THE MANUFACTURER'S REPRESENTATIVE, IT WAS DISCOVERED THAT THE DEVICE WAS IN AN OVERDISCHARGE CONDITION. A PHYSICIAN MODE RECHARGE (PMR) PROCEDURE WAS PERFORMED AND THE INS WAS RESTORED TO A WORKING STATUS. IT WAS NOTED THAT THE PATIENT HAS NOT HAD ANY PROBLEMS SINCE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425847 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1