BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2252071 · Received September 16, 2011

    Report

    Report Number
    3006630150-2011-01455
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2218-70, SERIAL # (B)(4), DESCRIPTION: ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCH STYLET MODEL # SC-1110-02, SERIAL # (B)(4) DESCRIPTION: IPG KIT (WITHOUT PULL-THROUGH TUNNELER).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S STIMULATION WAS INCREASING MUSCLE SPASMS THAT AGGRAVATE HER SEVERE SCOLIOSIS. THE PHYSICIAN WILL EXPLANT THE PATIENTS DEVICE ALTHOUGH THE PHYSICIAN DOES NOT BELIEVE THE DEVICE IS MAKING HER SCOLIOSIS WORSE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S STIMULATION WAS INCREASING MUSCLE SPASMS THAT AGGRAVATE HER SEVERE SCOLIOSIS. THE PHYSICIAN WILL EXPLANT THE PATIENTS DEVICE ALTHOUGH THE PHYSICIAN DOES NOT BELIEVE THE DEVICE IS MAKING HER SCOLIOSIS WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention