BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3092303 · Received May 3, 2013

    Report

    Report Number
    3006630150-2013-00933
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE WOUND WAS ISOLATED TO THE SUPERFICIAL SKIN WHERE THE LEAD EXTENSIONS HAD EXITED THE PATIENT¿S BODY. THE PHYSICIAN DID NOT SEE SIGNS OF INFECTION AROUND THE PADDLE LEAD OR EPIDURAL SPACE. THE PATIENT WAS DISCHARGED UNDER THE CARE OF AN INFECTIOUS DISEASE TEAM. IT IS INDICATED THAT THE DEVICES 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 SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-3138-35, SERIAL/LOT # (B)(4), DESCRIPTION: SCS PHIII EXTENSION 35CM; MODEL # SC-8216-70, SERIAL/LOT # (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A PERMANENT TRIAL THE PATIENT DEVELOPED AN ABSCESS AROUND HIS PADDLE LEAD. PURULENT DISCHARGE WAS NOTICED AT THE SITE OF THE LEAD EXTENSIONS. THE LEAD EXTENSIONS WERE CUT AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE PHYSICIAN BELIEVES THE ABSCESS WAS DEVICE AND PROCEDURE RELATED. THE PADDLE LEAD WILL BE EXPLANTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A PERMANENT TRIAL THE PATIENT DEVELOPED AN ABSCESS AROUND HIS PADDLE LEAD. PURULENT DISCHARGE WAS NOTICED AT THE SITE OF THE LEAD EXTENSIONS. THE LEAD EXTENSIONS WERE CUT AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE PHYSICIAN BELIEVES THE ABSCESS WAS DEVICE AND PROCEDURE RELATED. THE PADDLE LEAD WILL BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195263 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-3138-35 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention