BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6137899 · Received December 1, 2016

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    Report

    Report Number
    3004209178-2016-24943
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    September 15, 2016
    Report Date
    December 1, 2016
    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: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. 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

    THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE CONSUMER HAD A LEAD REVISION ON (B)(4) 2016 BECAUSE THEY WEREN'T FEELING STIMULATION IN THE CORRECT PLACE. DURING THAT TIME THE LEFT LEAD WAS COMPLETELY REMOVED. RELEVANT MEDICAL HISTORY INCLUDES NON-MALIGNANT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789374 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention