BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2802736 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09459
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7495LZ51 LOT# SERIAL# (B)(4), IMPLANTED: 2002 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7495LZ51 LOT# SERIAL# (B)(4), IMPLANTED: 2002 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7435 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3487A-33 LOT# J0206345V, IMPLANTED: 2002 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING SENSATION. THE REPORTER STATED, THE PATIENT WAS IN THE EMERGENCY ROOM AND DID NOT HAVE A PATIENT PROGRAMMER. IT WAS NOTED THAT THE SHOCKING STARTED THE MORNING OF THE REPORT. THE PATIENT HAD NOT EXPERIENCED A SHOCKING EPISODE PRIOR TO THIS ONE. NO FALLS OR INJURIES WERE REPORTED IN ASSOCIATION OF THIS EVENT. 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
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR