BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1953720 · Received January 4, 2011

    Report

    Report Number
    3006630150-2010-02233
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT LOCATION OF THE DISLODGED CONTACT OFF THE PADDLE LEAD WHICH WAS NOT RETURNED FOR ANALYSIS IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL AND PERFORMANCE TESTS DONE. A VISUAL INSPECTION OF THE PADDLE LEAD SHOWED THAT IT WAS CUT AT THE END. ELECTRODE #8 WAS ALSO COMPLETELY DISLODGED FROM THE PADDLE LEAD. THE DAMAGE DONE TO THE PADDLE LEAD IS CONSISTENT WITH DAMAGES DONE DURING AN EXPLANT PROCEDURE. A REVIEW OF THE STERILIZATION DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT HAD AN INFECTION. THE PT'S SYMPTOMS WERE FEVER, CHILLS AND DRAINAGE AT THE INCISION SITE. THE PT WAS EXPLANTED AND PRESCRIBED IV ANTIBIOTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION. THE PATIENT'S SYMPTOMS WERE FEVER, CHILLS AND DRAINAGE AT THE INCISION SITE. THE PATIENT WAS EXPLANTED AND PRESCRIBED IV ANTIBIOTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION. THE PATIENT'S SYMPTOMS WERE FEVER, CHILLS AND DRAINAGE AT THE INCISION SITE. THE PATIENT WAS EXPLANTED AND PRESCRIBED IV ANTIBIOTICS.

    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 64 YR Hospitalization| R ARTISAN 2X8 LIM, 70CM: MODEL#: SC-8216-70| SERIAL #: (B)(4)