BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2853592 · Received December 3, 2012

    Report

    Report Number
    3006630150-2012-02268
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN BELIEVED THE CRAMPING SENSATION WAS DUE TO THE ELECTRODE PLACEMENT. THE CRAMPING SENSATION WAS ALLEVIATED WITH REPROGRAMMING. NO FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL:SC-2218-50, SERIAL: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM MODEL: SC-1110-02, SERIAL: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING CRAMPING SENSATIONS ON HER BACK WHEN SHE USES THE DEVICE. A PAIN INJECTION WAS ADMINISTERED FOR THE CRAMPING SENSATION. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING CRAMPING SENSATIONS ON HER BACK WHEN SHE USES THE DEVICE. A PAIN INJECTION WAS ADMINISTERED FOR THE CRAMPING SENSATION. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention