BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3212648 · Received July 9, 2013

    Report

    Report Number
    9614453-2013-01469
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 12, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR AND THE PLUG REVEALED NO ANOMALY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3550-29, PRODUCT TYPE ACCESSORY. (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED IMPEDANCES WERE FLUCTUATING STRONGLY. IT WAS NOTED THE EXTENSION, CONNECTION, AND LEAD HAD BEEN REPLACED EARLIER TO DETERMINE IF THE SHOCKING WAS RELATED TO THOSE ITEMS, BUT THE PROBLEMS WERE NOT RESOLVED AFTER THAT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312218 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention