BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 7863967 · Received September 11, 2018

    Report

    Report Number
    3004209178-2018-20318
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    September 3, 2018
    Report Date
    September 20, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP). IT WAS REPORTED THAT AFTER RE-ORIENTING THE BATTERY AND PLAYING LAY BACK AS ZERO, THERE WERE NO MORE ISSUES. THE ISSUE HAS BEEN RESOLVED. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURER'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT USED ADAPTIVE STIMULATION AND FELT STIMULATION WHEN LYING BACK BUT WANTED THE VOLTAGE INTENSITY TO BE ZERO FOR THAT POSITION. THE PATIENT TRIED PROGRAMMING THE INTENSITY TO ZERO WITH THEIR PROGRAMMER, BUT THE INTENSITY RESUMED TO THE PREVIOUS PROGRAMMED LEVEL. THE NEXT TIME THEY WERE LYING BACK; THE PATIENT WAS CHANGING STIMULATION INTENSITY PRIOR TO LYING BACK AND WAITED 3-5 MINUTES TO ADDRESS STABILITY TIME AND FOR PROGRAMMING TO BE MEMORIZED. THE PATIENT LEANED FORWARD TO PAINT REGULARLY AND WANTED THEIR ADAPTIVE STIMULATION LYING FRONT POSITION TO ADDRESS THAT POSITION. THE PATIENT ALSO WANTED THE LYING LEFT PROGRAMMED POSITION TO ASSOCIATE WITH THE PATIENT'S ACTUAL LYING BACK POSITION. THE REPRESENTATIVE REORIENTED THE PATIENT PRIOR TO THE CALL, BUT THE SITUATION WAS UNCHANGED. THE REPRESENTATIVE WAS ADVISED TO ADJUST THE INTENSITY TO ZERO FOR ONE OF THE PATIENT'S PROGRAMS AT A TIME FOR THEIR LYING BACK POSITION TO DETERMINE IF ONE OR BOTH PROGRAMS WERE RESPONSIBLE FOR THE UNWANTED STIMULATION WHILE LYING BACK. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705241 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 58 YR