BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1923731 · Received December 9, 2010

    Report

    Report Number
    3006630150-2010-02100
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG PASSED ALL VISUAL, PHOTOGRAPHIC IMAGING, ELECTRICAL AND PERFORMANCE TESTS PERFORMED. THE DEVICE WAS MONITORED IN SALINE SOLUTION FOR SPURIOUS SIGNALS, AND NO ANOMALIES WERE NOTED. THE COMPLAINT OF DIFFICULTY CHARGING WAS NOT CONFIRMED. CHARGE PROFILE REVEALED VARIOUS TIMES OF ERRATIC COUPLING/POOR ALIGNMENT OF THE CHARGER TO THE IPG. THE REASON FOR THE ERRATIC COUPLING IS UNKNOWN. DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS. ANALYSIS ON LEAD (SC-2218-50 (B)(4)) REVEALED THAT THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. VISUAL INSPECTION OF THE LEAD (SC-2218-50 (B)(4))REVEALED THE LEAD WAS CUT APPROXIMATELY 16 INCHES FROM THE DISTAL END. THE DAMAGE TO THE LEAD IS 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 THE PT WOULD UNDERGO AN EXPLANT DUE TO THE DEVICE LOCATION MAKING THE PT'S SYMPTOMS WORSE AND DIFFICULTY CHARGING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO AN EXPLANT DUE TO THE DEVICE LOCATION MAKING THE PATIENT'S SYMPTOMS WORSE AND DIFFICULTY CHARGING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MODEL#: SC-2218-50, (B)(4)| ST LINEAR LEAD, 50 CM W/PRE-LOADED 0.014" STYLET| ST LINEAR LEAD, 50 CM W/PRE-LOADED 0.014" STYLET| MODEL#: SC-2218-50, (B)(4)