BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2003686 · Received February 23, 2011

    Report

    Report Number
    3006630150-2011-00257
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING, ELECTRICAL AND PERFORMANCE TESTS DONE. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. EXPLANTED LEAD, MODEL SC-2218-50 (B)(4), EXHIBITS NORMAL DEVICE CHARACTERISTICS. EXPLANTED LEAD, MODEL SC-2352-50 (B)(4), WAS FOUND THAT ELECTRODE #5 WAS FRACTURED RIGHT AT THE WELD NUGGET. THIS FAILURE COULD NOT CONTRIBUTE TO THE IPG SHUTTING OFF BY ITSELF. A REVIEW OF THE STERILIZATION DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    THE PATIENT REQUIRED AN EXTENDED HOSPITAL STAY. THE PATIENT WAS ALSO PRESCRIBED ORAL ANTIBIOTICS FOR THE INFECTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS FEELING THE STIMULATION SHUTTING OFF ON ITS OWN. UPON FURTHER REVIEW THE PHYSICIAN FELT THE LEAD WAS STARTING TO PROTRUDE THROUGH THE PATIENT'S SKIN. THE PATIENT THEN STARTED TO EXPERIENCE REDNESS AND SWELLING. THE PHYSICIAN EXPLANTED THE PATIENT'S ENTIRE SYSTEM DUE TO INFECTION AT THE LEAD AND POCKET SITE. THE PHYSICIAN FEELS THE INFECTION WAS RELATED TO THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS FEELING THE STIMULATION SHUTTING OFF ON ITS OWN. UPON FURTHER REVIEW THE PHYSICIAN FELT THE LEAD WAS STARTING TO PROTRUDE THROUGH THE PATIENT'S SKIN. THE PATIENT THEN STARTED TO EXPERIENCE REDNESS AND SWELLING. THE PHYSICIAN EXPLANTED THE PATIENT'S ENTIRE SYSTEM DUE TO INFECTION AT THE LEAD AND POCKET SITE. THE PHYSICIAN FEELS THE INFECTION WAS RELATED TO THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS FEELING THE STIMULATION SHUTTING OFF ON ITS OWN. UPON FURTHER REVIEW THE PHYSICIAN FELT THE LEAD WAS STARTING TO PROTRUDE THROUGH THE PATIENT'S SKIN. THE PATIENT THEN STARTED TO EXPERIENCE REDNESS AND SWELLING. THE PHYSICIAN EXPLANTED THE PATIENT'S ENTIRE SYSTEM DUE TO INFECTION AT THE LEAD AND POCKET SITE. THE PHYSICIAN FEELS THE INFECTION WAS RELATED TO THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R MODEL # SC-1110-02, (B)(4)| LINEAR 3-4 LEAD 50CM: MODEL # SC-2352-50,| IPG KIT WITHOUT PULL-THROUGH TUNNELER:| (B)(4)