BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3770100 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08046
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 17, 2014
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37712 SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES AND WAS FUNCTIONALLY OKAY. THE DEVICE PASSED THE FINAL FUNCTIONAL TEST. THE BATTERY WAS NOTED AS DISCHARGED. NO RECHARGE OR COUPLING ISSUES WERE OBSERVED WHEN TESTED AT ROOM TEMPERATURE WITH 1 CM SPACING. GOOD STABLE OUT WAS OBSERVED ON ELECTRODE PAIR SETTINGS THE DEVICE HAD WHEN RECEIVED. ANALYSIS OF LEAD MODEL 39565-65 LOT #V516608001 SHOWED NO SIGNIFICANT ANOMALIES. IT WAS NOTED THAT THE INSULATION WAS CUT THROUGH AND THE LEAD WAS SEGMENTED INTO 5 SEGMENTS. GOOD, STABLE OUTPUT WAS SEEN AND THE CONTINUITY WAS ACCEPTABLE WITH NO SHORTS WERE SEEN BETWEEN CIRCUITS. ANALYSIS OF BOTH ANCHOR ACCESSORIES SHOWED NO SIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, LOT# V516608001, IMPLANTED: 2010 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_SILICONE ANCHOR, SERIAL# UNKNOWN, EXPLANTED: 2014 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID NEU_SILICONEANCHOR, SERIAL# UNKNOWN, EXPLANTED: 2014 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) AND PADDLE LEAD WERE EXPLANTED DUE TO LOSS OF STIMULATION ON THE RIGHT SIDE. IT WAS NOTED THAT IT WAS NOT DEVICE RELATED. THE PRODUCTS WERE REPORTEDLY NOT REPLACED WITH OTHERS FROM THE SAME MANUFACTURER. THERE WAS NO REPORTED PATIENT DEATH OR INJURY AND THE PATIENT STATUS AFTER THE DEVICE WAS REMOVED WAS RECOVERED WITHOUT SEQUELAE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RECORDS INDICATED THAT THE PATIENT WAS SEEN ON (B)(6) 2013 FOR A STIMULATION CHECK AND (B)(6) 2013 FOR A SENSOR ADJUSTMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE WHO WORKED WITH THE PATIENT ON BOTH OCCASIONS WAS NO LONGER WORKING FOR THE MANUFACTURER. IT WAS NOTED THAT ACCORDING TO THE PATIENT, WHEN THE MANUFACTURER'S REPRESENTATIVE MET WITH HER IN (B)(6) HE STATED THAT "THERE WAS NOTHING MORE HE COULD DO FOR HER AND THAT THE SYSTEM COULD NOT GET ANY STRONGER." THESE ISSUES WERE REPORTEDLY NOT COMMUNICATED TO THE REST OF THE TEAM. IT WAS NOTED THAT IT WAS UNKNOWN IF ANY TROUBLESHOOTING WAS DONE. THE PATIENT HAD HAD GOOD RESULTS WITH A PREVIOUSLY IMPLANTED DEVICE FROM THE MANUFACTURER, BUT THIS DEVICE WAS REMOVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248642 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention