BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3250657 · Received July 26, 2013

    Report

    Report Number
    3004209178-2013-12378
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    July 1, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD NOT USED HER STIMULATOR FOR "AT LEAST TWO YEARS". IT WAS NOT REPORTED WHY. IT WAS STATED THAT THE STIMULATOR WAS UNABLE TO BE READ. AN OVERDISCHARGE WAS SUSPECTED. IT WAS UNKNOWN IF A PHYSICIAN-MODE-RECHARGE (PMR) WAS ATTEMPTED. IT WAS STATED THAT THE PHYSICIAN OPTED TO REPLACE THE DEVICE (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350039 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 Required Intervention