BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 5779734 · Received July 8, 2016

    Report

    Report Number
    3004209178-2016-13821
    Event Type
    Injury
    Date Received
    July 8, 2016
    Report Date
    July 10, 2017
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID (B)(4) LOT# VA005N5 SERIAL# IMPLANTED: (B)(4) 2012 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID (B)(4) LOT# VA05QGA SERIAL# IMPLANTED: (B)(4) 2013EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID (B)(4) LOT# VA0553W SERIAL# IMPLANTED: (B)(4) 2013 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID (B)(4) LOT# V931748 SERIAL# IMPLANTED: (B)(4) 2012 EXPLANTED: PRODUCT TYPE LEAD IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ERODING THROUGH THE SKIN. THE INS WAS IMPLANTED ON THE LEFT SIDE AND THEY WANTED TO REVISE IT OVER TO THE RIGHT SIDE. THE REP WAS INQUIRING ABOUT TUNNELING RECOMMENDATIONS. INDICATION FOR USE INCLUDED CERVICAL/NECK, AND SPINAL PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. IT WAS REPORTED THAT THE WIRES IN THE PATIENT¿S CHEST POPPED. THE PATIENT STATED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS PLACED UNDER THEIR ARM. ON (B)(6) 2016, THE PATIENT¿S PHYSICIAN HAD TO SEPARATE THE TWO WIRES BECAUSE THE TOP OF THE INS WAS GOING THROUGH THE PATIENT¿S ARMPIT AND WAS GOING TO FALL OUT. IT WAS NOTED THAT THE LEADS WERE SEPARATED AND SEWN TO THE PATIENT¿S MUSCLE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433004 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention