BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5223328 · Received November 13, 2015

    Report

    Report Number
    3004209178-2015-22780
    Event Type
    Injury
    Date Received
    November 13, 2015
    Report Date
    October 20, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 74002, LOT # N231712, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 3986A, LOT # LC3875, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 74002, LOT # N251257, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 3986A, LOT # N177352, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 748966, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 748940, SERIAL # (B)(46), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 748940, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    (B)(4). THE MANUFACTURER REPRESENTATIVE REPORTED THE PATIENT WAS SCHEDULED FOR A REPLACEMENT DUE TO EOL FROM 3 OVERDISCHARGES. THE HEALTHCARE PROFESSIONAL WOULD BE REPLACING THE IMPLANTABLE NEUROSTIMULATOR (INS) TO A NON-RECHARGEABLE INS. THE 3RD OVERDISCHARGE WAS CAUSED BY PATIENT NONCOMPLIANCE. THERE WERE NO PATIENT SYMPTOMS REPORTED AND THE OUTCOME WAS UNKNOWN. THE INDICATION FOR THERAPY WAS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752684 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention