BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 6146831 · Received December 6, 2016

    Report

    Report Number
    3006630150-2016-03527
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 11, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER INFORMATION COULD BE OBTAINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS NOT HEALING WELL. THE PHYSICIAN DID NOT KNOW THE CAUSE OF THE HEMATOMA, BUT IT WAS LOCATED IN THE POCKET SITE. IT WAS BELIEVED THAT THE PATIENT'S HEMATOMA WAS NOT DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-50, SERIAL #: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD KIT-50 CM. MODEL #: SC-3400-30, SERIAL #: INFINION SPLITTER 2X8 KIT (30 CM) DESCRIPTION: (B)(4). THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INFECTION AT THE POCKET SITE. SYMPTOMS WERE SWELLING, HEMATOMA, AND HEALING IMPAIRMENT. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DEVICE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INFECTION AT THE POCKET SITE. SYMPTOMS WERE SWELLING, HEMATOMA, AND HEALING IMPAIRMENT. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DEVICE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INFECTION AT THE POCKET SITE. SYMPTOMS WERE SWELLING, HEMATOMA, AND HEALING IMPAIRMENT. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798079 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention