BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2893075 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00037
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 10, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: 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: 37743, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL ABOUT THREE WEEKS PRIOR ON THEIR TAILBONE, MOSTLY ON THE LEFT SIDE. SINCE THE FALL WHEN STIMULATION WAS ON THE PATIENT WAS HUNCHED OVER AND NOT ABLE TO STRAIGHTEN UP. WHEN STIMULATION WAS OFF THE PATIENT WAS ABLE TO STRAIGHTEN UP. IT WAS NOTED THE PATIENT HAD STIMULATION OFF FOR AT LEAST TWO WEEKS. IT WAS NOTED THE PATIENT WAS HAVING A CT SCAN THE DAY OF REPORT. IT WAS ALSO NOTED THE PATIENT'S OTHER DEVICE WAS WORKING FINE SINCE FALL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT HAD A FALL "ABOUT THREE MONTHS AGO" FROM REPORT DATE, AND STATED SHE HAD THE SYSTEM CHECKED "WITH X-RAYS." IT WAS ALSO STATED WHEN THE PATIENT HAD THIS FALL, THE RIGHT SIDE "DIDN'T WORK." SHE STATED HER LEFT SIDE DID, HOWEVER, WORK. IT WAS REPORTED THE PATIENT WAS SENT A NEW PROGRAMMER "THE OTHER DAY" AND HAD SINCE THEN BEEN "WALKING CROOKED" AND HAD PAIN IN HER "STOMACH." THE PATIENT REPORTED THE LEFT SIDE IS "MESSED UP" EVER SINCE THE NEW PROGRAMMER WAS SENT. THE PATIENT REPORTED EVEN WHEN THE DEVICE WAS OFF, SHE STILL WALKED "CROOKED." THE PATIENT WAS RE-DIRECTED TO HER HEALTH CARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1