BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4110105 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17538
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 MEDICAL PRODUCTS: PRODUCT ID: 3708340, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708340, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39286-65, LOT# J0540959V, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A REVISION ON (B)(6) 2014 BECAUSE THE STIMULATION WAS NOT HIGH ENOUGH. THE OLD LEAD WAS REMOVED AND A NEW ONE WAS PLACED FOR BETTER COVERAGE. IT WAS UNKNOWN HOW LONG THIS WAS GOING ON FOR. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ALSO REPLACED DUE TO NORMAL BATTERY DEPLETION. IT WAS FURTHER REPORTED THAT THE REVISION WAS SUCCESSFUL. THE NEW LEAD WAS IMPLANTED AT A DIFFERENT THORACIC LEVEL. STIMULATION WITH THE NEW LEAD WAS CURRENTLY PROVIDING COVERAGE OF PAINFUL AREAS. NO DEVICES WERE GOING TO BE RETURNED TO THE DEVICE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590222 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention