BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 4013703 · Received August 15, 2014

    Report

    Report Number
    3004209178-2014-15419
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 24, 2013
    Report Date
    July 24, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A-33, LOT # J0313961V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 7495LZ25, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT # J0315961V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 7495LZ25, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT TOLD THE CALLER THAT THE IMPLANT HAD NOT BEEN WORKING FOR OVER A YEAR AND HAD BEEN ¿DEAD FOR OVER A YEAR.¿ THE CALLER STATED THAT THEY DID NOT KNOW WHY IT STOPPED WORKING. IT WAS NOTED THAT THE CALLER WAS AN MRI TECH (HEALTHCARE PROFESSIONAL/HCP) AND THEY DID NOT HAVE ANY ADDITIONAL INFORMATION ABOUT THE EVENT. IT WAS STATED THAT MRI COMPATIBILITY GUIDELINES WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489767 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR