BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2922926 · Received January 18, 2013

    Report

    Report Number
    3004209178-2013-00769
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 31, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3888-45, LOT# V956006, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT# VA00P29, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THERE WAS NO DEVICE MALFUNCTION. THE PATIENT FELL BUT IMPEDANCE MEASUREMENTS DID NOT INDICATE ANY ABNORMALITIES. IT WAS NOTED THAT THE PATIENT'S CYCLING PROGRAMMING WAS ELIMINATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S STIMULATION WAS TURNED ON (B)(6) 2012. AND THEY EXPERIENCED A 'BURNING' AND 'STINGING' SENSATION AT THE HIP WHERE THE LEAD WAS. IT WAS NOTED THE PATIENT FELL TWO DAYS PRIOR BUT THE 'BURNING' AND 'STINGING' WAS PRESENT PRIOR TO THE FALL. IT WAS NOTED THE PATIENT'S STIMULATION IS ON FOR FIFTEEN MINUTES THEN OFF FOR FIFTEEN MINUTES AND SO ON. THIS SEEMED TO BOTHER THE PATIENT SO THEY TURNED THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF UNTIL THEY COULD BE REPROGRAMMED AT THEIR NEXT APPOINTMENT WHICH WAS ON (B)(6) 2013. FOLLOW UP REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR REPRESENTATIVE. THE NEXT APPOINTMENT WAS SCHEDULED FOR (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NO FURTHER COMPLAINTS. THE PATIENT WAS DOING QUITE WELL AND WAS WALKING WITHOUT HER WALKER. IT WAS NOTED THAT THIS WAS A HUGE IMPROVEMENT FROM PRE-STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27518 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 00043 YR