BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2800428 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-09418
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    October 3, 2012
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED FOR A BATTERY REVISION ON (B)(6)-2012. IT WAS STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION AND LACK OF THERAPEUTIC EFFECT FOLLOWING MULTIPLE FALLS WITHIN THE LAST THREE MONTHS. THE PATIENT STATED THAT HER BLOOD PRESSURE CAUSED HER TO "PASS OUT;" THE PATIENT WAS VOMITING "SO MUCH SHE COULDN'T KEEP ANYTHING DOWN AND HER BLOOD PRESSURE HAD GONE SKY HIGH." THE PATIENT FELT THE 'PULSING' BEFORE SHE EVEN TURNED UP THE STIMULATION. THE PATIENT FELT STIMULATION WHEN INCREASING THE STIMULATION BUT STATED 'IT'S NOT LIKE IT WAS BEFORE' AND 'IT JUST ISN'T GOOD THERAPY.' THE PATIENT ALSO EXPERIENCED A 'PINCHING' SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) LOCATION WHEN SITTING AND STANDING. IT WAS NOTED THAT THERE WERE COUPLING AND COMMUNICATION ISSUES BETWEEN THE RECHARGER AND THE INS WITHIN THE LAST THREE MONTHS. THE PATIENT STATED THE RECHARGER DID NOT GO BEYOND 50 PERCENT AND AVERAGED ABOUT 4 TO 5 COUPLING BARS 'FOR ABOUT AN HOUR OR TWO,' WHICH THEN DECREASED TO 1 COUPLING BAR. ADDITIONAL INFORMATION WAS REQUESTED; IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention