BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6170877 · Received December 13, 2016

    Report

    Report Number
    3004209178-2016-26355
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 13, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109513
    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

    PRODUCT ID: 3888-28, LOT# N21823, IMPLANTED: (B)(6) 1994, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-28, LOT# N21823, IMPLANTED: (B)(6) 1994, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT WASN¿T RECEIVING STIMULATION. THE PATIENT HAD THEIR SYSTEM REPLACED A WEEK PRIOR TO THE DATE OF THIS REPORT AND ELEVATED IMPEDANCES WERE OBSERVED WHEN THEY CHANGED OUT THE IMPLANTABLE NEUROSTIMULATOR (INS). IMPEDANCE VALUES WERE 01 = 2204 OHMS, 02 = 5277 OHMS, 03= 4147 OHMS, 12 = 4076 OHMS, 13 = 3484 OHMS, 23 = 3827 OHMS. IT WAS REPORTED THAT THE IMPLANT WAS ON, BUT THE PATIENT WASN¿T RECEIVING THERAPEUTIC BENEFIT. THE PATIENT WASN¿T FEELING ANYTHING UP TO 10.5V. IT WAS NOTED THAT THE PATIENT¿S FIRST ATTEMPT TURNING ON THE INS WAS ON THE DATE OF THIS REPORT. ADDITIONAL INFORMATION PROVIDED REPORTED THAT REPROGRAMMING WAS ATTEMPTED BUT WASN¿T SUCCESSFUL. THE MANUFACTURER REPRESENTATIVE STATED THAT LEAD REVISION WAS PLANNED BUT HADN¿T BEEN SCHEDULED YET. THE PATIENT WAS TO FOLLOW UP WITH THEIR HEALTHCARE PROVIDER (HCP). INDICATION FOR USE IS SPINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823013 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702 00643169109513

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention