BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1943979 · Received December 3, 2010

    Report

    Report Number
    3006630150-2010-01889
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT WILL NOT PROCEED WITH THE LEAD REVISION PROCEDURE AT THIS TIME. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE LEADS FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT WAS NOT GETTING SUFFICIENT STIMULATION IN THE TARGET PAIN AREAS. AFTER ATTEMPTS AT REPROGRAMMING WERE UNSUCCESSFUL, THE BSN REP DISCOVERED MULTIPLE HIGH IMPEDANCE CONTACTS ON THE PT'S LEFT LEAD. IN ADDITION, AN X-RAY CONFIRMED A KINK IN THE PT'S LEFT LEAD. THE PT IS SCHEDULED TO UNDERGO A LEAD REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS NOT GETTING SUFFICIENT STIMULATION IN THE TARGET PAIN AREAS. AFTER ATTEMPTS AT REPROGRAMMING WERE UNSUCCESSFUL, THE BSN REPRESENTATIVE DISCOVERED MULTIPLE HIGH IMPEDANCE CONTACTS ON THE PATIENT'S LEFT LEAD. IN ADDITION, AN X-RAY CONFIRMED A KINK IN THE PATIENT'S LEFT LEAD. THE PATIENT IS SCHEDULED TO UNDERGO A LEAD REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2138-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR LINEAR LEAD, 50 CM WITH PRE-LOADED 0.012" STYLET:| MODEL# SC-2138-50, LOT# A11141