BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2882499 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12122
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    November 30, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, 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, PATIENT; PRODUCT ID 355531, LOT # N345563, IMPLANTED: (B)(6) 2012, PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS HAD SWELLING 4-5 TIMES IN THEIR LOW BACK, SPECIFICALLY THE IMPLANT AREA AND WHERE THE LEADS ARE. IT WAS STATED THAT THE SWELLING WAS CAUSING THE ELECTRODE ON THE LEFT SIDE OF THE SPINE "TO NOT WORK ON THAT SIDE OF THEIR BACK." IT WAS FURTHER STATED THAT ONLY THE RIGHT SIDE WORKS AND WAS "VERY IRRITATING." ICE WAS NECESSARY TO REDUCE THE SWELLING. THE STIMULATION ON THE LEFT SIDE WAS REPORTED AS "GOING IN AND OUT." THE PATIENT ALSO FELT STIMULATION "LESS" ON THE LEFT SIDE. IT WAS NOTED THAT THIS HAD BEEN OCCURRING SINCE THE "FOLLOW UP SURGERY WITH THE ORIGINAL IMPLANT." IT WAS STATED THAT IT LAST OCCURRED ABOUT A WEEK AGO. IT WAS INDICATED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH THE DOCTOR FOR EITHER (B)(6). IT WAS FURTHER REPORTED THAT THIS WOULD OCCUR WHEN THE PATIENT WAS STANDING STILL OR CHANGING POSITIONS. IT WAS ALSO REPORTED THAT IT WAS "REAL AGGRAVATING" THAT ONLY ONE SIDE WAS WORKING. IT WAS NOTED THAT IN (B)(4) 2012, THE MANUFACTURER REPRESENTATIVE HAD "SET IT THE SAME FOR BOTH SIDES." ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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