BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2870873 · Received December 12, 2012

    Report

    Report Number
    3004209178-2012-11777
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 16, 2012
    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

    PRODUCT ID 3888-56, LOT# V920378, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V964123, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT# V949385, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-56, LOT# V871403, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WIRE WAS CAUSING EXTREME PAIN IN HIS LOWER BACK, WHETHER THE IMPLANT WAS ON OR OFF. IT WAS NOTED THAT STIMULATION DID HELP WITH PAIN RELIEF, BUT THE PATIENT HAD EXTRA PAIN FROM THE LEADS. IT WAS REPORTED THAT THE PATIENT HAD AN UPCOMING SURGERY THAT WOULD BE HIS FOURTH SURGERY FOR HIS CURRENT IMPLANT. IT WAS UNCLEAR IF THE PREVIOUS SURGERIES AND UPCOMING SURGERY WERE RELATED TO THE LEAD PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAS CONCERNS ABOUT HIS DEVICE OR THERAPY AND IS WORKING WITH HIS HEALTHCARE PROFESSIONAL OR MANUFACTURER REPRESENTATIVE. NO FOLLOW-UP APPOINTMENTS WERE REPORTED. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THREE PAINFUL SURGERIES TO CORRECT EXTREME PAIN CAUSED BY THE ELECTRODES AFTER THE LEADS BROKE. SEE MFR. REPORTS # 3004209178-2015-01352 AND #3004209178-2013-12328 REGARDING OTHER SURGERIES, THE PATIENT HAD AFTER LEAD ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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