BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3173713 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10479
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    April 28, 2013
    Report Date
    May 28, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37754, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION REGARDING THIS EVENT WAS PREVIOULSY REPORTED UNDER MANUFACTURER REPORT # 3004209178-2013-14866. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED UNDER THIS REPORT #.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REVISED ON (B)(6). THE MANUFACTURING REPRESENTATIVE CHECKED THE PATIENT¿S RECHARGER POST-OPERATIVELY AND WAS ABLE TO GET 6 BARS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IN (B)(6) 2013 THE DEVICE WOULD NOT HOLD A CHARGE SO ON (B)(6) 2013 THE HEALTH CARE PROFESSIONAL (HCP) ORDERED A REVISION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RECHARGER SCREEN WAS UNRESPONSIVE AND ¿FROZEN¿ ON THE ANTENNA LOCATER SCREEN. IT WAS STATED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS DISCHARGED ¿PER THE PROGRAMMER¿ AND THE PATIENT HAD TROUBLE RECHARGING. REPORTEDLY, A COUPLING PROBLEM WAS REPORTED AND THE PATIENT HAD UNSUCCESSFULLY TRIED TO RECHARGE THEIR DEVICE FOR A MONTH PRIOR TO REPORT. IT WAS STATED THE CALLER COULDN¿T PALPATE THE INS AND COULD ONLY FEEL ONE EDGE. IT WAS NOTED THE PATIENT HAD HER THYROID REMOVED IN (B)(6) 2012, BEFORE HER INS IMPLANT, AND SHE GAINED 20 POUNDS AFTER THE THYROID REMOVAL AND HAS SINCE LOST 15 OF THOSE 20 POUNDS. IT WAS STATED THE CALLER WAS CONCERNED THE INS HAD SHIFTED IN THE POCKET DUE TO WEIGHT GAIN AND LOSS. IT WAS STATED THE PATIENT PLANNED TO HAVE A POCKET REVISION TO REMEDY THE SITUATION OF NOT BEING ABLE TO CHARGE FROM WEIGHT LOSS/GAIN. IT WAS STATED THEY WERE UNABLE TO PALPITATE THE POCKET, READ THE DEVICE WITH THE PHYSICIAN PROGRAMMER,RECHARGER OR PATIENT PROGRAMMER. THE POCKET REVISION WAS SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273990 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 00049 YR Required Intervention