BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 3142447 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08534
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37092, LOT# 285240002, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3 7743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED NO STIMULATION SENSATION. THE LAST TIME SHE USED HER PATIENT PROGRAMMER, SHE TURNED THE DEVICE DOWN LOW AND NOW IT WAS NOT WORKING. SHE LAST USED HER PATIENT PROGRAMMER 3-4 DAYS AGO. IT WAS NOTED THAT HER PATIENT PROGRAMMER WAS LOST AND A NEW ONE NEEDED TO BE ORDERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED ASSISTANCE FROM THE MANUFACTURING REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244422 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR