BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3171359 · Received June 14, 2013

    Report

    Report Number
    3006630150-2013-01228
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SC-1110-02 / (B)(4): A REVIEW OF STERILIZATION RECORDS FOUND THEM TO BE SATISFACTORY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. NO CORRECTIVE ACTION REQUIRED. MONITORING OF DEVICES RELATED TO INFECTION WILL BE CONTINUED AND CORRECTIVE ACTION WILL BE TAKEN AS NECESSARY. SC-2218-70: (B)(4): VISUAL INSPECTION REVEALED LEAD WAS CLEANLY CUT APPROXIMATELY 8 INCHES FROM THE DISTAL END. THE DAMAGE TO THE DEVICE IS CONSISTENT WITH DAMAGES DURING EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. NO CORRECTIVE ACTION IS REQUIRED. MONITORING OF DEVICES RELATED TO INFECTION WILL BE CONTINUED AND CORRECTIVE ACTION WILL BE TAKEN AS NECESSARY. SC-4316 / (B)(4): THE CLIK ANCHOR IS INTACT AND NO PARTS OF IT ARE MISSING. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. NO CORRECTIVE ACTION IS REQUIRED. MONITORING OF DEVICES RELATED TO ...

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM; MODEL #: SC-4316 SERIAL/LOT #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A PROCEDURE RELATED INFECTION AT THE POCKET AND LEAD SITES. THE PATIENT'S SYMPTOM INCLUDED DRAINAGE AT BOTH SITES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND DID WELL POSTOPERATIVELY. THE PATIENT'S INFECTION WAS ALSO RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A PROCEDURE RELATED INFECTION AT THE POCKET AND LEAD SITES. THE PATIENT'S SYMPTOM INCLUDED DRAINAGE AT BOTH SITES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND DID WELL POSTOPERATIVELY. THE PATIENT'S INFECTION WAS ALSO RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271183 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention