BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 6040660 · Received October 19, 2016

    Report

    Report Number
    3004209178-2016-22085
    Event Type
    Injury
    Date Received
    October 19, 2016
    Report Date
    January 25, 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
    TX, 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 MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. CORRECTION: PLEASE NOTE (B)(4) NO LONGER APPLIES TO THIS REPORT. 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

    (B)(4) NO LONGER APPLIES. 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

    ANALYSIS OF THE RETURNED INS (SERIAL # (B)(4)) FOUND THAT THE DEVICE WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. THE CONNECTOR MODULE WAS SCRATCHED. THE INS WAS FOUND TO HAVE GOOD STABLE OUTPUT AND PASSED THE FINAL FUNCTIONAL TEST. ANALYSIS OF THE RETURNED LEAD (SERIAL # (B)(4)) FOUND THAT ALL WIRES ON THE #8-15 LEAD LEG WERE BROKEN 2.8 CENTIMETERS FROM THE PROXIMAL END OF THE LEAD AND THE #0 WIRE ON THE #0-7 LEAD LEG WAS BROKEN UNDER THE WHITE SECTION 3-5 CENTIMETERS FROM THE PROXIMAL END. IT WAS ALSO FOUND THAT THE LEAD BODY INSULATION HAD BEEN CUT THROUGH AND THE LEAD WAS SEGMENTED. SEGMENTS 1 AND 2, THE TWO PROXIMAL SEGMENTS, HAD OPEN CIRCUITS WITH NO SHORTS BETWEEN CIRCUITS. SEGMENT 3, THE DISTAL FRAGMENT, HAD ACCEPTABLE CONTINUITY WITH NO SHORTS BETWEEN CIRCUITS. SET SCREW MARKS WERE OBSERVED IN THE CORRECT LOCATION. THERE WAS NO VISIBLE EVIDENCE OF ANY ANCHOR TYPE FOUND ON THE LEAD. (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

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

    Description of Event or Problem · 1

    A CONSUMER REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SHUTTING OFF INTERMITTENTLY. THE PATIENT WOULD TURN STIMULATION ON AND TURN AMPLITUDE TO THE HIGHEST AMOUNT AND THEY COULD NOT FEEL STIMULATION. THE INS WOULD TURN BACK ON SOMETIMES, AND THERE WAS NO PATTERN AND IT WAS VERY RANDOM. THE PATIENT DENIED ANY FALL OR OTHER EVENT. AN IMPEDANCE CHECK REVEALED ONE SIDE WAS OUT WHEN THE REP MET WITH THE PATIENT ON (B)(6). ADDITIONAL INFORMATION RECEIVED FROM THE REP INDICATED THEY WERE STILL WORKING WITH THE MANAGING OFFICE. THE PLAN WAS TO GET AN X-RAY TO SHOW IF THE PROXIMAL END OF THE LEAD WAS PLUGGED IN. THE INS WAS INDICATED FOR SPINAL PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THEY SPOKE WITH THE SURGEON'S OFFICE ON (B)(6) 2016, AND THE PLAN WAS TO TAKE THE PATIENT TO THE OPERATING ROOM (OR) FOR A POSSIBLE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) REVISION. IT WAS NOTED THE CASE HADN'T BEEN BOOKED YET.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A REP. IT WAS REPORTED THAT THE REP JUST RECEIVED THE EXPLANTED DEVICE ON 2016-NOV-30 FROM THE REP THAT COVERED THE REVISION CASE ON (B)(6) 2016. IMPEDANCE VALUES ON ELECTRODES 8-15 WERE GREATER THAN 10,000 OHMS AFTER CHECKING IN THE OPERATING ROOM AND THE SURGEON WANTED THE ENTIRE SYSTEM REPLACED. THE REASON FOR REMOVAL WAS THERAPY RELATED; THE PATIENT GRADUALLY HAD INTERMITTENT USE OF THE STIMULATOR AS IT TURNED ON/OFF INTERMITTENTLY. THE PATIENT WAS NOT IN A CLINICAL STUDY. THE INTENDED USE OF THE DEVICE WAS TREATMENT. THERE WAS NO PATIENT DEATH OR PATIENT INJURY. THE DEVICES WERE REPLACED WITH THE MANUFACTURER¿S PRODUCT. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT HAD A REMOVAL AND REPLACEMENT OF THEIR SYSTEM ON 2016-NOV-23. THE IMPEDANCES WERE STILL HIGH WHEN CHECKED IN THE OPERATING ROOM (OR), AND THE DOCTOR WASN¿T TO REPLACE THE ENTIRE SYSTEM. IT WAS STATED THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WOULD BE RETURNED FOR FURTHER ANALYSIS TO SEE WHY THIS WAS HAPPENING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REP INDICATED THAT THE REVISION WAS SCHEDULED FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690650 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