BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4123151 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17839
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 8, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37701, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION; PRODUCT ID 74002, LOT# N204144, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 389133, LOT# J0333773V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE SATURDAY BEFORE THE REPORT, THE PATIENT GOT A SEVERE SHOCK IN HER RIGHT ARM AND DOWN INTO HER RING FINGER AND INSIDE OF THE MIDDLE FINGER. IT CAUSED A BURNING SENSATION AND HER FINGERS GOT VERY RED. IT WAS STATED THAT IT FELT LIKE BURNING ON A BOILER AND THE FINGERS STAYED RED FOR A COUPLE OF DAYS. THE PATIENT WASN¿T TOUCHING ANY OTHER ELECTRICAL SOURCE AND IT WAS NOT LIKE A POSITIONAL CHANGE STIMULATION SENSATION. THE PATIENT HAD POST-SHOCK NUMBNESS IN HER WHOLE ARM. THE PATIENT WAS FEELING BETTER THE DAY OF THE REPORT. THE MANUFACTURING REPRESENTATIVE WAS NOTIFIED THE DAY BEFORE THE REPORT. IT WAS STATED THAT THIS HAS HAPPENED A COUPLE OF OTHER TIMES BUT NOT AS SEVERE, IT HAS HAPPENED IN THE LAST 3 OR 4 MONTHS BUT IT HAS NEVER BEEN REPORTED. IT WAS ALSO REPORTED THAT THE DOG MAY OR MAY NOT HAVE BEEN AFFECTED BY A SHOCK VIA THE PATIENT¿S FINGERS IN A DIFFERENT INCIDENT. THE PATIENT HAD A SHOCK COLLAR AND THAT WASN¿T ANYTHING COMPARED TO WHAT THE PATIENT¿S RECENT JO LT WAS LIKE. AN IMPEDANCE CHECK WAS DONE AS A DIAGNOSTIC AND RESULTS WERE FINE. THE PAIN PATTERN WAS IN THE CORRECT AREA, AND NO POWER ON RESET (POR) OR ERROR CODES WERE NOTED. THERE WAS NO EXPLANATION FOR WHAT THE PATIENT WAS DESCRIBING. IT WAS FELT THAT THE PATIENT MAY HAVE DEVELOPED SOME SENSITIVITY TO THE CATHODE AND THE ELECTRODE ARRAY WAS MOVED DOWN. THE PATIENT STILL HAD GOOD COVERAGE. THE PLAN WAS TO WATCH FOR ANY OTHER REPORTS AS ALL LOOKED FINE. . IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602887 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1