BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 9153675 · Received October 3, 2019

    Report

    Report Number
    3004209178-2019-18970
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    October 2, 2019
    Report Date
    January 7, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    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.

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT AND PRODUCT CODE APPLIES TO THIS EVENT DUE TO THE ADDITIONAL INFORMATION RECEIVED AND REPORTED IN SUPPLEMENTAL 001. 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 MANUFACTURER REPRESENTATIVE ON 2019-OCT-30 THAT THE CAUSE WAS NOT DETERMINED. THE PATIENT WAS PROGRAMMED AROUND THE HIGH IMPEDANCE. THE HEALTH CARE PROVIDER (HCP) DID NOT STATE ANY INTERVENTIONS WOULD BE TAKEN AT THAT TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON (B)(6) 2019 REPORTING THAT AFTER THE PROGRAMMING THEIR PAIN WAS WORSE. CALLER STATES THAT THEY WENT BACK TO USING A TENS UNIT AFTER THE PROGRAMMING MEETING BECAUSE THE DEVICE DOES NOT HELP THEIR PAIN ANYMORE. THE PATIENT REQUESTED ANOTHER PROGRAMMING SESSION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON 2019-DEC-19 REPORTING THAT THE PROGRAMMING SESSION RESOLVED THEIR PAIN TO A CERTAIN DEGREE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT ON (B)(6) 2019, THE REP MET WITH THE PATIENT AND RAN AN IMPEDANCE CHECK. THE PATIENT'S CURRENT PROGRAMMING AT THAT TIME WAS USING ELECTRODES 4 AND 10. HIGH IMPEDANCES (>40,000 OHMS) WERE FOUND ON THE FOLLOWING PAIRS WHEN RAN AT 3V: REFERENCE (REF) 15, 4 AND 10 WERE HIGH, REF 4, ALL CONTACTS WERE HIGH, REF 10, ALL CONTACTS WERE HIGH. ALL REFERENCE ELECTRODES AND ALL VALUES OTHER THAN 4 AND 10 WERE BETWEEN 500-1600 OHMS. THE REP RAN IMPEDANCES AGAIN AT 0.7V AND FOUND THAT ELECTRODES 3, 4, 7 AND 10 WERE THEN AROUND 10,000 OHMS. IT WAS REVIEWED WITH THE REP TO TRY AND AVOID ELECTRODES WITH HIGH IMPEDANCES. THE REP REPORTED THEY WOULD TRY TO REPROGRAM WITHOUT USING THE PROBLEMATIC IMPEDANCE VALUES. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947702 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR