BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2991686 · Received March 6, 2013

    Report

    Report Number
    3006630150-2013-00276
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: SC-2218-50 SERIAL/LOT#: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM MODEL #: SC-3138-55, SERIAL/LOT#: (B)(4), DESCRIPTION: SCS PHIII EXT 55CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT FINISHED THE COURSE ANTIBIOTICS AND THE INFECTION HAS CLEARED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPLANTED DUE TO AN (B)(6) INFECTION. THE PATIENT WAS EXPERIENCING REDNESS AND SORENESS THAT WAS NOT LOCALIZED AROUND THE DEVICES. THE PATIENT HAS HAD AN ONGOING CHALLENGE PRIOR TO THE IMPLANT AND IT BECAME WORSE POST-SURGERY OVER TIME. THERE WAS NOT A SUDDEN ONSET IMMEDIATELY AFTER THE SURGERY. ORAL AND IV ANTIBIOTICS WERE PRESCRIBED FOR THE PATIENT. IT IS UNDETERMINABLE IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPLANTED DUE TO AN METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION. THE PATIENT WAS EXPERIENCING REDNESS AND SORENESS THAT WAS NOT LOCALIZED AROUND THE DEVICES. THE PATIENT HAS HAD AN ONGOING CHALLENGE PRIOR TO THE IMPLANT AND IT BECAME WORSE POST-SURGERY OVER TIME. THERE WAS NOT A SUDDEN ONSET IMMEDIATELY AFTER THE SURGERY. ORAL AND IV ANTIBIOTICS WERE PRESCRIBED FOR THE PATIENT. IT IS UNDETERMINABLE IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96095 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention