BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4207760 · Received October 28, 2014

    Report

    Report Number
    3004209178-2014-20541
    Event Type
    Injury
    Date Received
    October 28, 2014
    Report Date
    October 2, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 377645, LOT# V010917, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 355029, LOT# N092748, IMPLANTED: 2006 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 37752, LOT# SERIAL# (B)(4); PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD THE FIRST BATTERY THAT HAD TO BE REPLACED BECAUSE, IT WAS ¿NOT WORKING SO GOOD.¿ THE PATIENT WAS UNSURE WHY THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. IT WAS NOT REPLACED DUE TO NORMAL BATTERY DEPLETION. THE PATIENT HAD TO HAVE ANOTHER ¿LINE¿ ADDED. IT WAS CLARIFIED THAT THE PATIENT HAD ANOTHER LEAD IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN IF THERE WAS A 50% OR GREATER SYMPTOMS REDUCTION. THE COMPONENT INVOLVED IN THE REPORTED EVENT WAS THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT DEVELOPED ELECTRIC SHOCKS RATHER THAN STIMULATION. REPROGRAMMING WAS DONE. THE GENERATOR WAS REPLACED AND PLACED NEW LEAD. THE CAUSE OF THE EVENT WAS NOT DETERMINED, AND WAS UNKNOWN IF IT WAS DEVICE RELATED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PATIENT HAD NOT BEEN SEEN IN CLINIC SINCE POST OP VISIT WAS DOING WELL AT THAT TIME, PRINT OUT NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688896 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention