BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6314363 · Received February 9, 2017

    Report

    Report Number
    3004209178-2017-02899
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    August 24, 2015
    Report Date
    March 24, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID: 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. DEVICE EVALUATION CODE OF (B)(4) IS FOR THE INS THAT WAS RETURNED, AND THE EVALUATION CODE OF (B)(4) IS FOR THE LEADS AS THEY WERE NOT RETURNED. 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS (NMD725527H) FOUND NO ANOMALIES. 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.

    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 FROM A CONSUMER VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE LEADS HAD MIGRATED THREE LEVELS LOWER AND THE HEALTHCARE PROVIDER (HCP) REVISED WITH A 5-6-5 PADDLE. IMPEDANCES ON 0-7 HAD FOUR CONTACTS THAT SHOWED IMPEDANCES >10,000. THE LEAD ALIGNMENT IN BATTERY ADJUSTED MULTIPLE TIMES, LEADS WERE CLEANED, AND SUCTION WAS USED TO VERIFY NO FLUID IN PORTS. THE LEAD WAS CONNECTED TO THE MULTI-LEAD TRIALING CABLE AND IMPEDANCES WERE BETWEEN 800-900. A NEW BATTERY WAS OPENED AND LEADS WERE CONNECTED AND IMPEDANCES SHOWED ALL IMPEDANCES BETWEEN 800-900. PATIENT IS NOW RECEIVING EFFECTIVE THERAPY. THE PATIENT DIDN'T REPORT ANY FALLS OR TRAUMA, BUT STATED THAT FROM THE TIME THEY WOKE UP FROM THE PREVIOUS REVISION THEY NEVER HAD GOOD COVERAGE AND ALWAYS SEEMED TO HAVE HAD ISSUES WITH THE DEVICE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE INS WAS RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101376 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention