BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3913671 · Received July 3, 2014

    Report

    Report Number
    6000032-2014-00134
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    December 12, 2000
    Report Date
    November 8, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# L87124, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2014: IT WAS REPORTED THAT THE PATIENT HAD PROBLEMS WITH THEIR ORIGINAL DEVICE; SPECIFICALLY THEY COULD NOT KEEP THE DEVICE ¿SET RIGHT.¿ THE DEVICE WAS REPORTEDLY REPLACED AND A SECOND IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391480 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Male Required Intervention "SEE H10...."