BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4222325 · Received November 4, 2014

    Report

    Report Number
    3006630150-2014-02529
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 9, 2013
    Report Date
    October 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER INFORMATION COULD BE OBTAINED AND THAT THERE WILL BE NO FURTHER COURSE OF ACTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE UNCOMFORTABLE FEELING WAS MORE ON THE PATIENT¿S RIBS WHENEVER THE STIMULATION WAS TURNED ON.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WILL BE NO FURTHER COURSE OF ACTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD STIMULATION IN THE CHEST AND STOMACH AND PATIENT EXPERIENCED DIFFICULTY BREATHING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD STIMULATION IN THE CHEST AND STOMACH AND PATIENT EXPERIENCED DIFFICULTY BREATHING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD STIMULATION IN THE CHEST AND STOMACH AND PATIENT EXPERIENCED DIFFICULTY BREATHING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD STIMULATION IN THE CHEST AND STOMACH AND PATIENT EXPERIENCED DIFFICULTY BREATHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706934 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention