BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2834039 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10316
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 17, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING RECHARGING ISSUES AND HIS DEVICE MAY BE FLIPPED. THE PATIENT "BUMPED" THE DEVICE ONE WEEK PRIOR TO THE REPORT AND THE AREA WAS SORE. THE MANUFACTURER REPRESENTATIVE DID NOT NOTE ANY SWELLING OVER THE DEVICE AND COULD NOT FEEL ANY WIRES OVER THE DEVICE. THE DEVICE DID "FEEL SLIGHTLY TILTED" AND "LOOSE" IN THE POCKET. IT WAS REPORTED THAT THE DEVICE WAS DIRECTLY UNDER THE INCISION, WHICH WAS UNUSUAL FOR THIS HEALTH CARE PROVIDER (HCP), AND X-RAYS WERE TO BE "DISCUSSED." ON (B)(6)2012, IT WAS REPORTED THAT THE PATIENT "CAUGHT THE DEVICE AREA ON A DOOR KNOW ABOUT A WEEK AGO." THE DEVICE WAS SUSPECTED TO HAVE BEEN FLIPPED BECAUSE THE "WIRES SEEMED TO BE COMING OUT OF THE TOP OF THE BATTERY." THE DEVICE WAS WORKING AND IN USE, BUT THE LACK OF RECHARGE COUPLING CONTINUED TO CAUSE EXTENDED RECHARGE TIMES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE FLIP WAS CONFIRMED. THE HCP WAS TO CORRECT THIS SURGICALLY, BUT NO DATE WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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