BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2071101 · Received April 27, 2011

    Report

    Report Number
    3006630150-2011-00604
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION REVEALED THE LEAD WAS CUT APPROXIMATELY 17 INCHES FROM THE PADDLE END. THE PROXIMAL END OF THE PADDLE LEAD WAS NOT RETURNED. THE DAMAGE TO THE DEVICE IS CONSISTENT WITH DAMAGES DURING EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE. NO COMPLAINTS ABOUT THE FUNCTIONALITY OF THIS DEVICE WERE REPORTED. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PADDLE LEAD WAS EXPLANTED DUE TO AN INFECTION AT THE BACK OF THE PATIENT'S NECK CAUSED BY LEAD MIGRATION. THE PATIENT'S SYMPTOMS INCLUDED OOZING AND REDNESS. THE PHYSICIAN BELIEVES THE INFECTION WAS PROCEDURE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PADDLE LEAD WAS EXPLANTED DUE TO AN INFECTION AT THE BACK OF THE PATIENT'S NECK CAUSED BY LEAD MIGRATION. THE PATIENT'S SYMPTOMS INCLUDED OOZING AND REDNESS. THE PHYSICIAN BELIEVES THE INFECTION WAS PROCEDURE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND WAS 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention