BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4418384 · Received January 14, 2015

    Report

    Report Number
    3004209178-2015-00693
    Event Type
    Injury
    Date Received
    January 14, 2015
    Report Date
    December 23, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3986A, LOT# N125489, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3986A, LOT# N140021, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4)

    Description of Event or Problem · 1

    THE PATIENT HAD RECHARGEABLE DEVICES IN THE PAST BUT HAD THEM REPLACED WITH NON-RECHARGEABLE DEVICES BECAUSE THE PATIENT HAD DIFFICULTY CHARGING THE DEVICES. THE DEVICES WERE LOCATED ON EITHER SIDE OF HER CHEST. THE COMPANY REPRESENTATIVE DID NOT KNOW THE CAUSE OF THE EVENT. THE PATIENT HAS HAD NO FURTHER ISSUES SINCE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32000 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 00045 YR Required Intervention