BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1983942 · Received February 7, 2011

    Report

    Report Number
    3006630150-2011-00189
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG PASSED VISUAL, PERFORMANCE, AND ELECTRICAL TESTS PERFORMED AND EXHIBITS NORMAL DEVICE CHARACTERISTICS. VISUAL INSPECTION OF THE LEAD ((B)(4))SHOWED THAT THE LEAD WAS CUT APPROXIMATELY SEVENTEEN INCHES FROM DISTAL END. DAMAGE TO THE LEAD IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. VISUAL INSPECTION OF THE LEAD ((B)(4)) DID NOT REVEAL ANY ANOMALIES. THE ROOT CAUSE OF THE REPORTED POCKET PAIN IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT'S ENTIRE PRECISION SYSTEM WAS EXPLANTED DUE TO POCKET SITE TENDERNESS AND SWELLING BUT NO INFECTION. THE PHYSICIAN BELIEVES THAT THE PT MAY HAVE BEEN ALLERGIC TO THE METAL, ALTHOUGH THE PT WAS NOT TESTED. THE PHYSICIAN NOTED THAT THE PT HAD SOME NECROSIS AND IT HAD CREATED A HOLE INSIDE THE PT'S POCKET. THE PT WAS DOING FINE FOLLOWING THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S ENTIRE PRECISION SYSTEM WAS EXPLANTED DUE TO POCKET SITE TENDERNESS AND SWELLING BUT NO INFECTION. THE PHYSICIAN BELIEVES THAT THE PATIENT MAY HAVE BEEN ALLERGIC TO THE METAL, ALTHOUGH THE PATIENT WAS NOT TESTED. THE PHYSICIAN NOTED THAT THE PATIENT HAD SOME NECROSIS AND IT HAD CREATED A HOLE INSIDE THE PATIENT'S POCKET. THE PATIENT WAS DOING FINE FOLLOWING 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 24 YR Required Intervention (B)(4)| ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET| (B)(4)| MODEL# SC-2218-50