BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 6111607 · Received November 17, 2016

    Report

    Report Number
    3004209178-2016-24308
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    April 1, 2016
    Report Date
    April 24, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    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

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3777-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2017, PRODUCT TYPE LEAD; PRODUCT ID 3777-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. ANALYSIS OF THE INS ((B)(4)) FOUND THE INS TO BE FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES.

    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

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    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

    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

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT FELT THAT AS THE IMPLANTABLE NEUROSTIMULATOR (INS) DEPLETED IT WAS HEATING UP AND WAS PAINFUL. THE PATIENT KNEW WHEN TO CHARGE AND WHEN THE INS WAS ON THE LAST QUARTILE BECAUSE OF THE HEATING SENSATION. MANUFACTURER REPRESENTATIVE INDICATED STIMULATION WAS OFF WHEN THE PATIENT CAME IN TO SEE THE MANUFACTURER REPRESENTATIVE BUT THAT THEY WERE USING THE SYSTEM. THE MANUFACTURER REPRESENTATIVE STATED THAT THE PATIENT HAD A PERIPHERAL NERVE STIMULATOR (PNS) SO THE LEADS RAN PARALLEL ON EACH SIDE OF THE PATIENT¿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¿NOT PRESS TOO HARD.¿ THE MANUFACTURER REPRESENTATIVE BELIEVED STIMULATION AS OFF DURING PALPATION SO THE PATIENT DID NOT REPORT ANY CHANGES IN STIMULATION UPON PALPATION. THE INS HAD BEEN HEATING FOR THE LAST 6-7 MONTHS IN 2016.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP). THE REP RETURNED THE INS AND LEADS AND WAS AWARE OF THE COMPLAINTS ON THE DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REPORTING THAT THE PATIENT'S INS HAD BEEN REPLACED ON (B)(6) 2017 AND WOULD BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE ONLY THING THEY WERE AWARE OF BEING DONE ON (B)(6) WAS TRYING TO PROGRAM AROUND THE CONTACTS WITH THE HIGH IMPEDANCES. THE REP. FOLLOWED UP WITH THE CONSUMER AFTER (B)(6) WHO STATED THE HEATING AND SORENESS AT THE IMPLANT SITE ALONG WITH THE RAPID DEPLETION LESSENED AFTER REPROGRAMMING WAS PERFORMED TO AVOID THE HIGH IMPEDANCES BUT WAS STILL THERE, AND THEIR PARASTHESIA COVERAGE WAS LESS. THE REP. THEN SPOKE WITH THE PHYSICIAN WHO PLANNED TO SEE THE CONSUMER FOR A CONSULT AFTER THE HOLIDAYS TO SCHEDULE TO REPLACE THE ENTIRE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759602 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention