BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1980348 · Received February 2, 2011

    Report

    Report Number
    3006630150-2011-00145
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPLANTED. THE REASON GIVEN FOR THE EXPLANT WAS THAT THE PATIENT DOESN'T USE THE DEVICE AND ELECTED TO HAVE IT REMOVED. NOTHING WAS MENTIONED REGARDING ALLERGIC REACTION. THE PHYSICIAN DOESN'T WANT TO PROVIDE ANY ADDITIONAL INFORMATION. THE PATIENT IS DOING WELL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-1110-02 (B)(4) DESCRIPTION: IPG KIT WITHOUT PULL-THROUGH TUNNELER THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT IS EXPERIENCING A SEVERE ALLERGIC REACTION TO THE LIPS AND FACE AREA. THE PHYSICIAN HAS PRESCRIBED THE PT STEROID MEDICATION AND OTHER MEDICATION WITH NO SUCCESS. THE PHYSICIAN IS GOING TO EXPLANT THE PADDLE LEAD TO SEE IF THE ALLERGIC REACTION WILL RESOLVE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING A SEVERE ALLERGIC REACTION TO THE LIPS AND FACE AREA. THE PHYSICIAN HAS PRESCRIBED THE PATIENT STEROID MEDICATION AND OTHER MEDICATION WITH NO SUCCESS. THE PHYSICIAN IS GOING TO EXPLANT THE PADDLE LEAD TO SEE IF THE ALLERGIC REACTION WILL RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention