BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3103412 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07488
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 3550-39 LOT# N320829, IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (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

    PRODUCT ID: 3550-39, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED NO ANOMALY. FINAL ANALYSIS OF THE TWO TITAN ANCHORS REVEALED NO ANOMALIES. FINAL ANALYSIS OF THE LEAD REVEALED NO SIGNIFICANT ANOMALY, THE LEAD BODY WAS CUT THROUGH, AND THE PRODUCT WAS SEGMENTED. IT WAS NOTED THAT THE SETSCREWS WERE TIGHT TO THE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS "SO NERVOUS AND STARTED CRYING". IT WAS NOTED THAT THE PATIENT WAS HAVING "EDEMAS" AS WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION THAT STARTED "1.5 MONTHS AFTER IMPLANT." THE REPORTER STATED THAT "HER BODY STARTED ITCHING AND HER FACE GOT SWOLLEN." IT WAS FURTHER NOTED THAT THE PATIENT HAD TO GO TO THE ER FOR MEDICATION BECAUSE HER FACE WAS "SO SWOLLEN." IT WAS NOTED THAT THE PATIENT WAS PUT ON PREDNISONE AND WAS REFERRED TO AN ALLERGIST. IT WAS FURTHER NOTED THAT THE PATIENT WAS NOT ALLERGIC TO ANY MEDICATION OR FOODS. THE RESULTS OF AN ALLERGY TEST SHOWED THAT THE PATIENT WAS "POSITIVE TO TWO COMPONENTS OF THE STIMULATOR," BUT THE PATIENT DID NOT KNOW WHICH ONES. THE REPORTER STATED THAT SHE COULD "INCREASE STIMULATION TOO MUCH BECAUSE THAT WOULD WORSEN THE ALLERGY." IT WAS NOTED THAT THE PATIENT CONTINUED TO TAKE PREDNISONE FOR THE ALLERGY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT TWO MONTHS LATER, THE PATIENT HAD THE DEVICE EXPLANTED. IT WAS NOTED THAT THE PATIENT "COMPLAINED OF FACIAL SWELLING AND GENERALIZED URTICARIA." IT WAS REPORTED THAT THE LEAD REMAINED IMPLANTED, BUT IT WAS LATER INDICATED THAT THE LEAD HAD BEEN EXPLANTED AND WAS RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE PATIENT HAD BEEN TAKING ORAL MEDICATIONS, CORTISONE, AND LEVOCETIRIZINE. ADDITIONAL INFORMATION RECEIVED THREE DAYS LATER REPORTED THAT THE PATIENT HAD BEEN ADVISED BY HER ALLERGIST TO HAVE THE SYSTEM REMOVED BECAUSE "SHE WAS ALLERGIC TO ONE OF THE COMPONENTS." IT WAS NOTED THAT THE SPECIFIC COMPONENT WAS UNKNOWN. IT WAS NOTED THAT PATIENT WAS RECEIVING GREATER THAN 50% RELIEF OF HER CHRONIC BACK AND LEG PAIN. IT WAS UNCLEAR WHETHER THE PATIENT'S PAIN RELIEF WAS FELT PRIOR TO EXPLANT OR AFTER EXPLANT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203259 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 00049 YR Required Intervention