BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4173191 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19711
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    October 9, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 7754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD 4 REVISIONS IN 2013 BECAUSE THEY FEEL THEIR HEALTH CARE PROVIDER (HCP) DOES NOT KNOW WHAT THEY ARE DOING. THE PATIENT¿S 3RD REVISION WAS BECAUSE THE PATIENT¿S ANCHORS/LEADS HAD TO BE REDONE. NO OUTCOME WAS PROVIDED HOWEVER ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654317 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