BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7288571 · Received February 22, 2018

    Report

    Report Number
    3004209178-2018-03748
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    January 27, 2018
    Report Date
    April 5, 2018
    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
    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

    FDC (B)(4) APPLIES TO DESKTOP CHARGER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DESKTOP CHARGER (B)(4) FOUND THAT CONNECTOR PIN WAS BROKEN. THE DESKTOP CHARGER (B)(4). FDC 11 APPLIES TO THE DESKTOP CHARGER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICATION COMPONENT IS PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 37761 , SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4) APPLY TO DESKTOP CHARGER. DEVICE CODE (B)(4) APPLY TO IMPLANTABLE NEUROSTIMULATOR (INS). FDC APPLIES TO IMPLANTABLE NEUROSTIMULATOR (INS). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT. WHEN ASKED WHAT CIRCUMSTANCE THAT LED TO IMPLANT DISCHARGED, PATIENT STATED THE IMPLANT HAD CHARGED SOME, PATIENT HAD TO TURNED STIMULATION UP TO STOP THE PAIN, BUT IT WAS HARDER FOR PATIENT TO WALK. IT WAS NOTED THE REPLACEMENT OF THE RECHARGER AND DESKTOP CHARGER RESOLVED THE PATIENT¿S IMPLANT DISCHARGING. NO FURTHER COMPLICATION AND EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A CONSUMER WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR CHRONIC LOW BACK PAIN AND SPINAL PAIN. IT WAS REPORTED THE PATIENT HAD DAMAGED CHARGER AND WAS CALLING THE MANUFACTURER TO RETURN. IT WAS NOTED THE CHARGER WILL BE REPLACED IN THE FUTURE BY A MANUFACTURER PRODUCT. IT WAS MENTIONED THE PIN WAS BROKEN ON CHARGER AND THE PATIENT¿S BATTERY WAS DISCHARGED. THE PATIENT WAS CALLING ON MONDAY TO HAVE THE UNIT REPLACED. THE ISSUES WERE NOT RESOLVED AT THE TIME OF REPORT. AT ABOUT 2 DAYS LATER, AN ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT. IT WAS REPORTED THE METAL LITTLE PRONGS WERE MESSED UP INSIDE AND INS RECHARGER COULD NOT CHARGE. ON (B)(6) 2018, PATIENT SAID SHE GOT THE DESKTOP CHARGER AND STILL COULD NOT CHARGE HER CHARGER. ON (B)(6) 2018, PATIENT SAID PATIENT STILL HADN¿T RECEIVED THE INS RECHARGER. IT WAS NOTED CONNECTOR PIN WAS BROKEN. NO FURTHER COMPLICATION AND NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134046 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR