BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2103091 · Received May 25, 2011

    Report

    Report Number
    3006630150-2011-00758
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2138-70 SERIAL# (B)(4) DESCRIPTION: LINEAR LEAD, 70 CM WITH PRE-LOADED 0.012 INCHES STYLET.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2352-50 SERIAL# (B)(4) DESCRIPTION: LINEAR 3-4 LEAD 50CM; MODEL# SC-3138-25 SERIAL# (B)(4) DESCRIPTION: PHASE III LEAD EXTENSION - 25 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICES 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 PATIENT WAS NOT RECEIVING ADEQUATE STIMULATION. DURING THE LEAD REVISION PROCEDURE, THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY INSERT THE LEAD IN THE HEADER OF THE LEAD EXTENSION AS THE END OF THE LEAD WAS BENT AND A CONTACT WAS SQUASHED. THE PHYSICIAN DECLINED EXPLANTING THE DAMAGED LEAD AND CHOSE TO INSERT THE FUNCTIONING LEAD IN THE IPG. THE LEAD WAS THEN TESTED FOR IMPEDANCES AND DISCOVERED THAT THERE WERE HIGH IMPEDANCES ON BOTH LEADS. UPON FURTHER INVESTIGATION, IT APPEARED THAT THE SET SCREW ON THE IPG WAS NOT TIGHTENED; THEREFORE NO COMMUNICATION WAS ABLE TO BE OBTAINED BETWEEN BATTERY AND LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS NOT RECEIVING ADEQUATE STIMULATION. DURING THE LEAD REVISION PROCEDURE, THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY INSERT THE LEAD IN THE HEADER OF THE LEAD EXTENSION AS THE END OF THE LEAD WAS BENT AND A CONTACT WAS SQUASHED. THE PHYSICIAN DECLINED EXPLANTING THE DAMAGED LEAD AND CHOSE TO INSERT THE FUNCTIONING LEAD IN THE IPG. THE LEAD WAS THEN TESTED FOR IMPEDANCES AND DISCOVERED THAT THERE WERE HIGH IMPEDANCES ON BOTH LEADS. UPON FURTHER INVESTIGATION, IT APPEARED THAT THE SET SCREW ON THE IPG WAS NOT TIGHTENED; THEREFORE NO COMMUNICATION WAS ABLE TO BE OBTAINED BETWEEN BATTERY AND LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention