BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2991603 · Received March 6, 2013

    Report

    Report Number
    3006630150-2013-00383
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S LEADS MIGRATED OUT OF HER HEAD. THE PATIENT UNDERWENT A REVISION, DURING WHICH, THE PHYSICIAN ELECTED TO REPLACE THE LEADS AND THE IPG. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2352-50 SERIAL / LOT #: (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PERCUTANEOUS LEADS LOCATED ON THE BASE OF HER SKULL POKED OUT THROUGH HER SKIN AND WAS EXPERIENCING PAIN AND SHOCKING SENSATIONS. THE PHYSICIAN ENDED UP PUTTING BACK THE LEADS INSIDE. WEEKS AFTER THE LEADS HAD POKED AGAIN THROUGH HER SKIN. THEY ENDED UP CUTTING THE DISTAL PORTION OF THE LEADS AND TUCKED IT INSIDE THE BODY. THE PATIENT WAS DOING FINE AND NO SIGN OF INFECTION WAS NOTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PERCUTANEOUS LEADS LOCATED ON THE BASE OF HER SKULL POKED OUT THROUGH HER SKIN AND WAS EXPERIENCING PAIN AND SHOCKING SENSATIONS. THE PHYSICIAN ENDED UP PUTTING BACK THE LEADS INSIDE. WEEKS AFTER THE LEADS HAD POKED AGAIN THROUGH HER SKIN. THEY ENDED UP CUTTING THE DISTAL PORTION OF THE LEADS AND TUCKED IT INSIDE THE BODY. THE PATIENT WAS DOING FINE AND NO SIGN OF INFECTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95449 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention