BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 10155241 · Received June 15, 2020

    Report

    Report Number
    3004209178-2020-10354
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    April 17, 2020
    Report Date
    June 15, 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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377860, LOT#: V003662, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 377860, SERIAL/LOT#: (B)(4), UBD: 16-FEB-2010, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO IS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT USUALLY RECHARGES THE IMPLANTABLE NEUROSTIMULATOR AND THEN USES THE PATIENT PROGRAMMER TO TURN STIMULATION BACK ON; HOWEVER, WHEN THE PATIENT DID THIS ON (B)(6) 2020, THE IMPLANTABLE NEUROSTIMULATOR WOULD NOT TURN ON. AT THE TIME OF THE CALL, THE IMPLANTABLE NEUROSTIMULATOR WAS CONFIRMED TO BE ON; HOWEVER, THE PATIENT WAS NOT FEELING STIMULATION. THE STIMULATION WAS DESCRIBED AS A WATERFALL SENSATION. THE PATIENT INCREASED FROM 5.10 VOLTS UP TO OVER 7.0 VOLTS AND DID NOT FEEL STIMULATION. THE PATIENT DECREASED TO 5.2 VOLTS. ADAPTIVESTIM WAS ENABLED. AFTER TURNING ADAPTIVESTIM OFF AND INCREASING STIMULATION, THE PATIENT WAS STILL NOT FEELING STIMULATION. ADAPTIVESTIM WAS TURNED BACK ON. TURNING THE STIMULATION ON AND OFF ALSO DID NOT RESOLVE THE ISSUE. THE PATIENT HAS NOT HAD ANY RECENT FALLS OR TRAUMA WHICH MAY HAVE CONTRIBUTED TO THE ISSUE. THE PATIENT ONLY HAS GROUP A, PROGRAM 1 PROGRAMMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE REP FOUND THE WIRE WAS NO LONGER WORKING AND SWITCHED TO A DIFFERENT WIRE. PATIENT STATED THROUGH THE REPS (B)(6) THEY SWITCHED THE PATIENT FROM DEAD WIRE TO ANOTHER WIRE AND NOW IT WORKS GREAT. ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615852 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR