BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 3241401 · Received July 22, 2013

    Report

    Report Number
    3006630150-2013-01538
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 12, 2013
    Report Date
    October 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL/LOT #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD WITH PLATNALOCK TECHNOLOGY - 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD BURNING SENSATION AND PAIN AT THE POCKET SITE. OTHER SYMPTOM INCLUDED SWELLING AT THE SITE. DUE TO THE LONG-TERM BRUISING/DISCOLORATION AT THE BATTERY SITE, THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD BURNING SENSATION AND PAIN AT THE POCKET SITE. OTHER SYMPTOM INCLUDED SWELLING AT THE SITE. DUE TO THE LONG-TERM BRUISING/DISCOLORATION AT THE BATTERY SITE, THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340507 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 14664738

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention