BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2091926 · Received May 18, 2011

    Report

    Report Number
    3006630150-2011-00686
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE THERE WAS NO NERVE DAMAGE. THERE WAS EPIDURAL SCARING WHICH WAS THE RESULT OF THE EPIDURAL INFECTION. THE PHYSICIAN BELIEVES THE EPIDURAL SCARING WAS PROCEDURE RELATED. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-1110-02 (B)(4) MODEL DESCRIPTION:IPG KIT (WITHOUT PULL-THROUGH TUNNELER) MODEL#:SC-8216-70 (B)(4) MODEL DESCRIPTION:ARTISAN 2X8 PADDLE LEAD (LIM), 70 CM

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS INDICATED DAMAGE TO PADDLE LEAD (B)(4) IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. NO ANOMALIES WERE DETECTED WITH THE IPGS. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF PADDLE LEAD (B)(4) FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED RESPIRATORY COMPLICATIONS AFTER THE IMPLANT PROCEDURE AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAD TO BE PLACED ON A VENTILATOR AS SHE HAD STOPPED BREATHING. WHILE IN THE HOSPITAL, THE PATIENT REPORTED PAIN AT THE LAMINECTOMY SITE AND WAS PLACED ON VICODIN. AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT WENT TO THE ER FOR PAIN AND DRAINAGE AT THE INCISION SITE. THE PHYSICIAN EXPLANTED BOTH SYSTEMS DUE TO INFECTION THAT CAUSED SOME NERVE DAMAGE IN THE SHOULDER FROM THE CERVICAL LEAD PLACEMENT. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED RESPIRATORY COMPLICATIONS AFTER THE IMPLANT PROCEDURE AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAD TO BE PLACED ON A VENTILATOR AS SHE HAD STOPPED BREATHING. WHILE IN THE HOSPITAL, THE PATIENT REPORTED PAIN AT THE LAMINECTOMY SITE AND WAS PLACED ON VICODIN. AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT WENT TO THE ER FOR PAIN AND DRAINAGE AT THE INCISION SITE. THE PHYSICIAN EXPLANTED BOTH SYSTEMS DUE TO INFECTION THAT CAUSED SOME NERVE DAMAGE IN THE SHOULDER FROM THE CERVICAL LEAD PLACEMENT. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED RESPIRATORY COMPLICATIONS AFTER THE IMPLANT PROCEDURE AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAD TO BE PLACED ON A VENTILATOR AS SHE HAD STOPPED BREATHING. WHILE IN THE HOSPITAL, THE PATIENT REPORTED PAIN AT THE LAMINECTOMY SITE AND WAS PLACED ON VICODIN. AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT WENT TO THE ER FOR PAIN AND DRAINAGE AT THE INCISION SITE. THE PHYSICIAN EXPLANTED BOTH SYSTEMS DUE TO INFECTION THAT CAUSED SOME NERVE DAMAGE IN THE SHOULDER FROM THE CERVICAL LEAD PLACEMENT. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R