BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3132919 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08268
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 3, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PATIENT WAS HAVING NUMBNESS IN BOTH LEGS, WITH THE RIGHT LEG HAVING BEEN WORSE. IT WAS REPORTED THE PATIENT HAD WHAT FELT LIKE A CYST IN THE POCKET SITE. THE PATIENT WENT TO URGENT CARE ON (B)(6) 2013 BUT WAS TURNED AWAY DUE TO NOT TREATING PAIN STIMULATION THERAPY. IT WAS REPORTED THE PATIENT¿S SYMPTOMS OCCURRED FOLLOWING A POSITION CHANGE. APPROXIMATELY A WEEK PRIOR TO (B)(6) 2013 THE PATIENT HAD BEEN WORKING AND SITTING FOR 9.5 HOURS STRAIGHT, AND WHEN THEY STOOD UP THEY ¿DIDN¿T FEEL RIGHT.¿ THE PATIENT HAD TRIED MULTIPLE SETTINGS ON THE DEVICE AND TURNED STIMULATION OFF FOR 48 HOURS BUT THEIR NUMBNESS PERSISTED. IT WAS LATER REPORTED THE PATIENT HAD BEEN SEEN THE DAY OF REPORT BY A MANUFACTURER¿S REPRESENTATIVE AND THE DEVICE WAS PROGRAMMED. IT WAS REPORTED THE PATIENT¿S COVERAGE SEEMED TO CHANGE AND THE PATIENT¿S PHYSICIAN THOUGHT THE LEAD HAD MOVED. THE PATIENT WAS SCHEDULED TO RECEIVE AN X-RAY AND WAS SCHEDULED TO SEE THE PHYSICIAN ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235376 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