BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 7977730 · Received October 18, 2018

    Report

    Report Number
    3004209178-2018-23319
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    March 17, 2018
    Report Date
    October 18, 2018
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT IDZ: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE AND A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT A LEAD MIGRATION OCCURRED WHICH WAS CONFIRMED VIA X-RAY IMAGING; THERE WERE NO KNOWN ENVIRONMENTAL FACTORS THAT MIGHT HAVE LED TO THIS ISSUE. THE PATIENT LOST THEIR PAIN PATTERN COVERAGE. THE SYSTEM WAS REPLACED- THERE WAS NO ISSUE WITH THE PATIENT'S INS OR SECOND LEAD BUT THE PHYSICIAN OPTED TO UPGRADE THE INS AND LEAD. THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821902 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention