BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2870357 · Received December 12, 2012

    Report

    Report Number
    3006630150-2012-02342
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    FIELD SHOULD BE (B)(4) 2012.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO SCIATICA AND INADEQUATE PAIN RELIEF. DURING THE PROCEDURE, THE PHYSICIAN EXPLANTED THE IPG AND PREFERRED TO HAVE THE LEADS REMAIN IMPLANTED. THE PHYSICIAN BELIEVES THE IPG LOCATION MAY HAVE CAUSED SCIATICA AND DISCOMFORT AT THE POCKET SITE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO SCIATICA AND INADEQUATE PAIN RELIEF. DURING THE PROCEDURE, THE PHYSICIAN EXPLANTED THE IPG AND PREFERRED TO HAVE THE LEADS REMAIN IMPLANTED. THE PHYSICIAN BELIEVES THE IPG LOCATION MAY HAVE CAUSED SCIATICA AND DISCOMFORT AT THE POCKET SITE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention