BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4960892 · Received August 3, 2015

    Report

    Report Number
    3004209178-2015-14525
    Event Type
    Injury
    Date Received
    August 3, 2015
    Report Date
    July 16, 2015
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-56, LOT# V061227, IMPLANTED:(B)(6) 2007, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED:(B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6)2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3888-56, LOT# V061227, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED:(B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED:(B)(6) 2015, PRODUCT TYPE: LEAD, PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED:(B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3888-56, LOT# V061227, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# V061227, IMPLANTED: (B)(6) 2007, EXPLANTED:(B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED ADEQUATE RELIEF AFTER THE DEVICE WAS INITIALLY IMPLANTED. HOWEVER, THE LEADS BECAME DISLODGED TWO SEPARATE TIMES. AFTER THE LAST DISLODGEMENT THE PATIENT DID NOT RECEIVE ADEQUATE RELIEF. THIS ISSUE OCCURRED ONCE THE LEADS WERE REPOSITIONED AFTER DISLODGEMENT OCCURRED. X-RAYS, IMPEDANCE CHECKS, AND REPROGRAMMING WERE COMPLETED. SURGICAL REVISIONS WERE ALSO PERFORMED ON UNKNOWN DATES. THE SYSTEM WAS EXPLANTED PER THE PATIENT¿S REQUEST SINCE THE DEVICE WAS NOT PROVIDING PAIN RELIEF. THE ISSUE WAS NOT RESOLVED AT THE TIME IF THE REPORT. IT WAS UNKNOWN WHY THE LEADS DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503976 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention