BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3301133 · Received August 21, 2013

    Report

    Report Number
    3004209178-2013-14946
    Event Type
    Injury
    Date Received
    August 21, 2013
    Report Date
    July 25, 2013
    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
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708260 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3998 LOT# V010366, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37713, SERIAL #(B)(4) SHOWED NO SIGNIFICANT ANOMALIES AND SHOWED A REDUCED BATTERY CAPACITY DUE TO OVERDISCHARGE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVERDISCHARGED. THE REPORTER STATED A PHYSICIAN MODE RECHARGE (PMR) SUCCESSFULLY RESET THE INS, BUT THE INS WOULD NOT HOLD A CHARGE. IT WAS NOTED THE PATIENT HAD THEIR INS REPLACED ON 2013 (B)(6). IT WAS FURTHER NOTED THAT THERE WERE NO PATIENT SYMPTOMS. IT WAS NOTED THE MANUFACTURING REPRESENTATIVE SAW THE PATIENT ON 2013 (B)(6) AND THEY WERE GETTING GOOD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406059 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