BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3930431 · Received July 11, 2014

    Report

    Report Number
    3006630150-2014-01571
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    April 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A DIAGNOSTIC TEST. THE NEUROLOGIST STATED THAT THE PATIENT HAD RESTLESS LEG SYNDROME AND RECOMMENDED TO INCREASE GABAPENTIN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-1110-02, SERIAL/LOT #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LEG JERKS WHEN STIMULATION IS ON OR OFF. THE PHYSICIAN PRESCRIBED A MUSCLE RELAXANT BUT IT DIDN¿T ALWAYS HELP WITH THE JERKING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LEG JERKS WHEN STIMULATION IS ON OR OFF. THE PHYSICIAN PRESCRIBED A MUSCLE RELAXANT BUT IT DIDN¿T ALWAYS HELP WITH THE JERKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406764 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention