BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 6636445 · Received June 13, 2017

    Report

    Report Number
    3004209178-2017-12705
    Event Type
    Injury
    Date Received
    June 13, 2017
    Report Date
    January 26, 2018
    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
    NJ, 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

    SUPPLEMENTAL TO UPDATE CODES, ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (B)(4 ) FOUND THAT IT WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT A NOMALIES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVENT IS NOW REPORTABLE FOR SERIOUS INJURY. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID (B)(4) LOT# V002869 IMPLANTED: (B)(4) 2006: PRODUCT TYPE LEAD. 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. 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 PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME, MULTIPLE BACK OPERATIONS AND SPINAL PAIN VIA A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT SOMETIMES UPON GETTING OUT OF BED, THE PATIENT FELT LIKE STIMULATION GOT VERY STRONG. THE REP REPORTED THAT THE PATIENT DENIED ANY FALLS. THE REP REPORTED THAT IMPEDANCE 0-3 WAS GREATER THAN 10,000 OHMS AND HAD NOT USED THESE CONTACTS SINCE (B)(6) 2014. THE REP REPORTED THAT ALL IMPEDANCE 8-11 WERE WITHIN NORMAL LIMITS. THE REP REPORTED THAT THEY TRIED TO REPRODUCE THE COMPLAINT OF STIMULATION INTENSITY CHANGE WITHOUT SUCCESS. THE REP REPORTED THAT THEY RECHECKED IMPEDANCE IN OFFENDING POSITION PALPATION AND STILL WAS WITHIN NORMAL LIMITS. THE REP REPORTED THAT ELECTRODE AND GROUP IMPEDANCE WAS WITHIN NORMAL LIMITS. THE REP REPORTED THAT THE PATIENT WAS REPROGRAMMED. THE REP REPORTED THAT THEY HAD THE PATIENT MOVE IN AND OUT OF POSITION THAT WOULD OCCASIONALLY CAUSE INTENSITY CHANGE AND NO CHANGE WAS NOTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). IT WAS REPORTED THE PATIENT HAD A LEAD REVISION SCHEDULED AND WHEN THE HEALTHCARE PROFESSIONAL (HCP) OPENED THE INS POCKET, THERE WAS A LARGE DENT ON THE DEVICE. THE REP STATED THE PATIENT WAS HAVING A SHOCKING SENSATION AT THE INS SITE WHEN STIMULATION WAS TURNED ON. THE REP REPORTED THE PATIENT WAS GETTING GOOD THERAPY. THE LEAD WAS SHOWING IMPEDANCES OF >40,000 OHMS PRIOR TO SURGERY IN CONTACTS 4-7. THE REP STATED WHEN THEY ATTEMPTED TO REPLACE THE LEAD, PART OF THE LEAD WAS FRAYED AND BROKE OFF WHERE THE LEAD/EXTENSION SITE WAS. THE HCP WAS ABLE TO RETRIEVE THE BROKEN PIECE AND REMOVED IT. IT WAS MENTIONED THE 4-7 LEAD TAIL WAS NOT CONNECTED TO ANYTHING. IT WAS REPORTED ALL OF THE EXPLANTED COMPONENTS WOULD BE RETURNED. THE INS WAS REPLACED AND THE 4-7 LEAD TAIL WAS CURRENTLY NOT BEING USED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418309 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 Required Intervention