BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 7146370 · Received December 26, 2017

    Report

    Report Number
    3006630150-2017-05261
    Event Type
    Injury
    Date Received
    December 26, 2017
    Date of Event
    December 5, 2017
    Report Date
    December 26, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8352-50, SERIAL #: (B)(4). DESCRIPTION: COVERED GE X 32, 50 CM 4X8 SURGICAL LEAD A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE PRODUCTS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING EXTREME PAIN AT THE POCKET SITE. THE SIDEWAYS WERE BRUISED, TENDER TO TOUCH AND CANNOT CHARGE WELL. IT WAS REPORTED THAT THE PATIENT WAS HAVING INFECTION AT THE IPG SITE. SYMPTOMS OF REDNESS AND BULGING AROUND THE AREA WERE NOTED. THE PHYSICIAN BELIEVED IT WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926004 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention