BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3230321 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11870
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 21, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER; PATIENT PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009: PRODUCT TYPE: LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009: PRODUCT TYPE: LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS WITH AN HCP A WEEK AGO AND HAD BEEN HAVING BACK TROUBLE. IT WAS NOTED THAT THE PATIENT HAD A COLONOSCOPY ON (B)(6) 2013 AND AFTER THAT HER BACK WAS GIVING HER TROUBLE AGAIN. THE PATIENT THOUGHT THAT IT HAD TO DO WITH HOW THEY MOVED HER DURING THE COLONOSCOPY. IT WAS NOTED THAT FOR 11 DAYS AFTER THAT SHE WAS ON VICODIN AND ICING HER BACK TO RELIEVE THE PAIN. 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
    329000 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 00069 YR