BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2655422 · Received July 13, 2012

    Report

    Report Number
    3004209178-2012-05612
    Event Type
    Malfunction
    Date Received
    July 13, 2012
    Report Date
    June 14, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: LEAD: MODEL 3998, LOT# V110881, IMPLANTED: (B)(6) 2008, EXPLANTED: NA. EXTENSION: MODEL 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA. EXTENSION: MODEL 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA. PROGRAMMER: MODEL 37743, SERIAL# (B)(4). RECHARGER: MODEL 37752, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. STIMULATION COULD BE FELT IN HER RIGHT SIDE, BUT SHE NEEDED IT IN HER LEFT SIDE. THE PATIENT HAD BEEN TOLD ONE YEAR AGO THAT PROGRAMMING OPTIONS HAD BEEN EXHAUSTED. THE PATIENT WONDERED IF A CHIROPRACTOR COULD MOVE THE LEADS BACK INTO PLACE, BUT NOTED THAT NO IMAGING OPTIONS HAD BEEN DONE TO CONFIRM LEAD MIGRATION. 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
    1 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