BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 14503712 · Received May 26, 2022

    Report

    Report Number
    3004209178-2022-06781
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    January 1, 2006
    Report Date
    May 25, 2022
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-45, LOT#: V012532, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD, PRODUCT ID: 3487A-45, LOT#: V013263, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3487A-45, SERIAL/LOT #: (B)(4), UBD: 20-SEP-2010, UDI#: (B)(4); PRODUCT ID: 3487A-45, SERIAL/LOT #: (B)(4), UBD: 05-OCT-2010, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (MRI TECH) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAS A LOOSE LEAD. PER THE PATIENT, THIS OCCURRED APPROXIMATELY 10 WEEKS AFTER IMPLANT. THERE WERE NO PATIENT SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342800 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male