BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2901559 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-00301
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_WRENCH_ACC, PRODUCT TYPE ACCESSORY PRODUCT ID, NEU_UNKNOWN _LEAD, 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

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (INS 37714 RESTORE SENSOR, SERIAL# (B)(4)) FOUND ITS CONNECTOR PORT OBSTRUCTED BY MEDICAL ADHESIVE. MEDICAL ADHESIVE WAS OBSTRUCTING THE LOWER PORT BETWEEN THE 14TH AND 15TH BALSEALS. A KNOWN GOOD LEAD WOULD NOT PASS THROUGH THIS AREA PREVENTING FULL INSERTION OF THE LEAD. INITIAL OUTPUT AND FINAL FUNCTIONAL TESTS WERE NOT PERFORMED DUE TO THE OBSTRUCTION IN THE PORT. ACCESS HOLE OBSERVATIONS FOUND BUBBLES BETWEEN CIRCUIT FEEDS. ANALYSIS OF THE WRENCH ACCESSORY FOUND NO ANOMALY.

    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, THE BATTERY WAS "DEFECTIVE." IMPEDANCES ON 8-15 WERE GREATER THAN 40,000. IT WAS NOTED THAT IMPEDANCES ON 8 AND 13 WERE NORMAL. THE LEADS WERE SWITCHED AND THEY GOT THE SAME IMPEDANCE READINGS. THE PORT WAS SUCTIONED AND THEY RECONNECTED 5-6 TIMES WITH THE SAME ISSUE. AN X-RAY WAS TAKEN OF THE BATTERY AND EVERYTHING WAS ALIGNED, ANOTHER PROGRAMMER WITH NO RESOLVE. THE BATTERY WAS NOT IMPLANTED. ANOTHER BATTERY WAS USED AND WORKED FINE WITH NO ISSUES. IT WAS NOTED BECAUSE OF THE HIGH IMPEDANCES AN EXTRA 25 MINUTES WAS ADDED ON TO THE CASE. IT HAD BEEN DETERMINED INTRAOPERATIVELY THAT IT WAS NOT A PROBLEM WITH THE LEAD AND THAT THE LEAD WAS "MAINTAINED" THE ENTIRE TIME. FOLLOW UP REPORTED THE PATIENT WAS RECEIVING GOOD THERAPY WITH THE SECOND DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT WAS DOING WELL. REVIEW OF INFORMATION RECEIVED INDICATED THE SAME EVENT WAS REPORTED IN MANUFACTURER'S REPORT #3007566237-2013-00094 AND #3007566237-2013-00116. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT WILL BE REPORTED UNDER THIS MANUFACTURER REPORT #. THE ISSUE WAS RESOLVED INTRA-OPERATIVELY - NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8567 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