BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7225058 · Received January 29, 2018

    Report

    Report Number
    3004209178-2018-01556
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    January 8, 2018
    Report Date
    March 6, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IS AN ESTIMATE AS THE EVENT STARTED IN (B)(6) 2018 WITH NO SPECIFIC DAY REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3888-56, LOT# V181443, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3888-56, LOT# V181443, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3777-60, (B)(4) SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. ADDITIONAL REVIEW INDICATED (B)(4) ARE NO LONGER APPLICABLE TO THE EVENT. 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 BY THE CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAS BEEN HAVING ELECTRICAL SURGES ON THEIR SIDE. THE PATIENT WAS GOING TO SEE THEIR PHYSICIAN AND COMPANY REPRESENTATIVE (REP) ON (B)(6) 2018 TO DETERMINE IF THE IMPLANT WAS DEFECTIVE AND IF THEY ARE GOING TO NEED A WHOLE NEW REPLACEMENT. IF THE IMPLANT WAS TURNED OFF, THERE WERE NO ELECTRICAL SURGES. THE EVENT DATE WAS UNKNOWN. IT WAS UNKNOWN IF ANY TROUBLESHOOTING/DIAGNOSTICS/ACTIONS WERE PERFORMED. THE OUTCOME OF THE EVENT WAS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THEY WERE EXPERIENCING SURGES ON THEIR LEFT SIDE EVERY TIME THEY MOVED. THE PATIENT STATED THAT THE CAUSE OF THE ELECTRICAL SURGES WAS DUE TO A PROBLEM WITH THE THORACIC LEAD AND THAT THEY HAD TO TURN IT OFF. IT WAS NOTED THAT THE ISSUE WAS NOT RESOLVED, AS THE PATIENT STILL HAS THE ISSUE WHEN THEY TURN ON THE LEADS HIGHER IN THAT AREA. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER REPORTING THE PATIENT EXPERIENCED ZAPS. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2018 WITH THEIR DOCTOR AND COMPANY REPRESENTATIVE (REP) TO CHECK THEIR IMPLANT. THE REP NARROWED DOWN THE LOCATION OF THE ISSUE TO THE EXTENSIONS. SOME LEADS NEED EXTENSIONS. ONE LEAD MAY BE SHORTING OUT, A MISFIRE ON THE PATIENT¿S SIDE WHERE THE IMPLANT WAS. THE REP TURNED OFF A LEAD SO NOW THE IMPLANT WAS NOT PULSATING TO STOP THE PAIN. THE PATIENT REPORTED PAIN WHERE THE IMPLANT WAS SUPPOSED TO BE HELPING AND DISCOMFORT. THE PATIENT TURNED OFF THE IMPLANT ON THE NIGHT OF THEIR APPOINTMENT AND WAS UNCOMFORTABLE WITH IT NOT TURNED ON. THE PATIENT WILL HAVE A SECOND APPOINTMENT WITH THEIR DOCTOR AND REP TO RECHECK THE IMPLANT, BUT IT WAS UNSCHEDULED AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69743 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR