BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2935864 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01140
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT STIMULATION TURNED ON AND OFF AND SOMETIMES JOLTED THE PATIENT. THIS WAS NOTED TO HAVE OCCURRED FOR A FEW MONTHS FOLLOWING A FALL THE PATIENT HAD. THE PATIENT REPORTEDLY TOOK A "BIG UGLY SPILL" IN (B)(6) THE PREVIOUS YEAR AND SINCE THEN WOULD LOSE HER BALANCE AND FALL. ADDITIONALLY, THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF AND STIMULATION COVERED THE PATIENT'S LOW BACK AND BILATERAL LEG. HOWEVER, IMPEDANCE TESTS INDICATED THAT PROGRAMMED ELECTRODES WERE LOW AND IN RANGE. THE REPORTER ALSO STATED THAT IT WAS NOT POSSIBLE TO REPLICATE THE VARIABILITY OR JOLTING OF STIMULATION IN THE HEALTHCARE PROVIDER (HCP'S) OFFICE. THE PATIENT WAS REPROGRAMMED OBTAINING BETTER COVERAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT NOTICED HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS "NOT WORKING RIGHT" ON (B)(6) 2013. THE PATIENT WAS FEELING STIMULATION "IN RIB CAGE AND AROUND THE FRONT." IT WAS STATED THAT IF THE PATIENT "MOVES JUST RIGHT" SHE COULD FEEL A "TWINGE IN THE FRONT AND DOWN HER LEGS." IT WAS REPORTED THAT THE PATIENT SAW HER HEALTH CARE PROVIDER (HCP) A "FEW WEEKS AGO" AND HAD AN INJECTION. IT WAS NOT STATED WHAT THE INJECTION WAS FOR. IT WAS NOTED THAT THE HCP DID NOT PERFORM AN X-RAY. FURTHER INFORMATION WAS REQUESTED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41436 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 00053 YR