BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 8864392 · Received August 6, 2019

    Report

    Report Number
    3004209178-2019-15034
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    August 27, 2018
    Report Date
    August 22, 2019
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, LOT# UNK, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, LOT# UNKNOWN, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) IN A CLINICAL STUDY (SDY). IT WAS REPORTED THAT THE CLINICAL DIAGNOSIS WAS EROSION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT IN A CLINICAL STUDY (SDY) WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT THE WIRE WAS OCCASIONALLY STICKING OUT AND BECAME SENSITIVE TO TOUCH. A PHYSICAL EXAMINATION FOUND THERE WAS LEAD MIGRATION/DISLODGEMENT AT THE LOWER BACK; THE SITE OF THE WIRE INSERTION AND LOOPS OF THE WIRE. THIS WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018 WHEN THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659623 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention