BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6608924 · Received June 2, 2017

    Report

    Report Number
    3004209178-2017-11554
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    April 1, 2017
    Report Date
    June 22, 2017
    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

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 377845, LOT# V001727, PRODUCT TYPE: LEAD. PRODUCT ID: 377845, LOT# V001523, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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. IT WAS REPORTED THAT THE PATIENT HAD NEW LEADS PUT IN ABOUT A WEEK PRIOR TO THE DATE OF THIS REPORT. THE MANUFACTURER REPRESENTATIVE STATED THAT THE PATIENT WAS DOING VERY WELL NOW. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT. IT WAS REPORTED THAT THE PATIENT STILL WASN¿T GETTING STIMULATION ON THEIR LEFT SIDE AFTER BEING IMPLANTED WITH THEIR NEW DEVICE. REPROGRAMMING WAS ATTEMPTED, BUT IT DIDN¿T RESOLVE THE ISSUE. THE MANUFACTURER REPRESENTATIVE STATED THAT THE PATIENT WAS ONLY ABLE TO GET STIMULATION IN THEIR RIGHT ABDOMEN. IMPEDANCES WERE RAN AND CONTACTS 4-7 HAD VALUES GREATER THAN 10,000 OHMS. THE MANUFACTURER REPRESENTATIVE STATED THAT X-RAYS SHOWED THAT THE PATIENT ONLY HAD FOUR ELECTRODES. IT WAS REVIEWED THAT THE MANUFACTURER REPRESENTATIVE SHOULD RE-CONFIGURE THE PATIENT¿S LEAD TO 1X4 SINCE THERE WERE ONLY FOUR ELECTRODES. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. INDICATION FOR USE IS OTHER CHRONIC/INTRACTABLE PAIN (TRUNK/LIMBS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390413 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention