BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2022826 · Received March 17, 2011

    Report

    Report Number
    3006630150-2011-00371
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    December 7, 2010
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD PASSED PHOTOGRAPHIC IMAGING TESTS. EXTERNAL VISUAL INSPECTION REVEALED THAT THE LEAD WAS DAMAGED. THE PADDLE END IS MISSING ELECTRODES. ONE OF THE ELECTRODE WAS PARTIALLY DISLODGED FROM THE PADDLE END. ELECTRICAL TESTS COULD NOT BE PERFORMED DUE TO PADDLE LEAD DAMAGES. THE SURGICAL PROCEDURE COMMENTS STATED THAT THE PHYSICIAN NOTED DIFFICULTY WHILE EXPLANTING THE PADDLE LEAD AND SIX CONTACTS HAD FALLEN OFF AND BECAME DISLODGED. THE PHYSICIAN IS NOT SURE HOW THE CONTACTS FELL OFF, AND DOES NOT KNOW IF THE CONTACTS FELL OFF DURING THE EXPLANT PROCEDURE. IT WAS CONFIRMED VIA X-RAY THAT NO CONTACTS REMAINED IN THE PATIENT. THE PADDLE LEAD DAMAGES ARE A RESULT OF THE EXPLANT PROCEDURE AND ARE NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING UNDESIRED STIMULATION. A BSN SALES REPRESENTATIVE ATTEMPTED TO REPROGRAM THE PATIENT, HOWEVER WAS UNSUCCESSFUL. AN X-RAY WAS TAKEN AND CONFIRMED LEAD MIGRATION. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTIES EXPLANTING THE PADDLE LEAD AS SIX CONTACTS FELL OFF AND BECAME DISLODGED. THE PHYSICIAN SUCCESSFULLY REMOVED THE CONTACTS AND THE PATIENT IS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING UNDESIRED STIMULATION. A BSN SALES REPRESENTATIVE ATTEMPTED TO REPROGRAM THE PATIENT, HOWEVER WAS UNSUCCESSFUL. AN X-RAY WAS TAKEN AND CONFIRMED LEAD MIGRATION. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTIES EXPLANTING THE PADDLE LEAD AS SIX CONTACTS FELL OFF AND BECAME DISLODGED. THE PHYSICIAN SUCCESSFULLY REMOVED THE CONTACTS AND THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention