BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4802194 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-09824
    Event Type
    Injury
    Date Received
    May 28, 2015
    Report Date
    May 5, 2015
    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: 3708160, SERIAL# (B)(4) IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37081, SERIAL# (B)(4) IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37081, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A FALL WHERE SHE FELL ON HER RIGHT SIDE WHILE CARRYING HER GRANDCHILD. SINCE THE FALL, THE PATIENT HAS FELT SHOCKING OR ZAPPING AROUND HER SPINE AREA WHERE HER LEAD IS. THE SHOCKING OCCURS WHEN THE PATIENT MOVES IN CERTAIN WAYS. STIMULATION IN THE WRONG LOCATION WAS REPORTED. SINCE THE FALL, THE PATIENT IS FEELING STIMULATION IN THE POCKET AREA, ESPECIALLY WHEN TRYING TO PROGRAM VOLTAGE AT HIGHER VALUES. WHEN THE COMPANY REPRESENTATIVE WAS TRYING TO REPROGRAM TODAY, COULD GET STIMULATION INTO THE PATIENT¿S LEGS WITH SOME SETTINGS BUT ¾ OF THE TIME THE STIMULATION TENDS TO BE IN THE POCKET AREA. THE PATIENT WAS BARELY FEELING STIMULATION AT HIGHER VOLTAGES AND THE COMPANY REPRESENTATIVE HAS TO INCREASE TO 8.5 TO 10V TO GET THE PATIENT TO FEEL ANYTHING. BEFORE THE FALL, THE PATIENT WAS USING 7-8V FOR STIMULATION NEEDS BUT TURNED DOWN TO 6V AFTER THE FALL DUE TO SHOCKING THAT WAS OCCURRING. ELECTRODE IMPEDANCES WERE IN THE NORMAL RANGE; TAKEN AT 3V WITH 0 AS REFERENCE IMPEDANCES RANGE FROM 530-664. WITH 1 AS REFERENCE, IN 400- 500S. WITH 2 AS REFERENCE, THEY WERE NORMAL RANGE BUT PAIRS WITH 7 AND 8 WERE IN THE 300S. WITH 3 AS REFERENCE 8, 9, AND 14 WERE IN THE 300S WITH OTHER NORMAL RANGE. WITH 4 AS REFERENCE, 9 WAS IN 300S. ELECTRODE 5 AS REFERENCE DOESN¿T HAVE ANY VALUES IN THE 300S. THE NEXT DAY THE PATIENT¿S COMPLAINTS REMAINED UNCHANGED. THE DOCTOR WAS GOING TO GET X-RAYS AND THE PATIENT WILL MOST LIKELY UNDERGO A REVISION. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2015. THE EXTENSIONS WERE REPLACED. THE PATIENT DENIED FURTHER COMPLAINTS OF SHOCKING AND REPORTED DESIRED COVERAGE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345169 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 00048 YR Required Intervention