BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2212073 · Received August 15, 2011

    Report

    Report Number
    3006630150-2011-01285
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-3108-35, SERIAL # (B)(4), DESCRIPTION: LEAD EXTENSION, 35 CM.

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS FOR LEAD EXTENSION (B)(4) (MD# SC-3108-35) CONFIRMED THE COMPLAINT. VISUAL INSPECTION OF THE DEVICE FOUND THAT THE CONNECTOR BLOCK WAS RIPPED OFF FROM THE LEAD EXTENSION BODY. VISUAL INSPECTION OF LEAD (B)(4) (MD# SC-2108-30M) REVEALED LEAD WAS CUT APPROXIMATELY 10 INCHES FROM DISTAL END. THE DAMAGES TO THE LEAD AND LEAD EXTENSION ARE CONSISTENT WITH DAMAGES DONE DURING THE EXPLANT PROCEDURE AND ARE NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION DUE TO LEAD MIGRATION, THE PHYSICIAN DISCOVERED THAT ONE OF THE LEADS WAS FRACTURED. THE PHYSICIAN REPLACED THE LEAD ALONG WITH ONE LEAD EXTENSION. THE PATIENT WAS REPROGRAMMED AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION DUE TO LEAD MIGRATION, THE PHYSICIAN DISCOVERED THAT ONE OF THE LEADS WAS FRACTURED. THE PHYSICIAN REPLACED THE LEAD ALONG WITH ONE LEAD EXTENSION. THE PATIENT WAS REPROGRAMMED AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2108-30M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention