BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2000975 · Received February 18, 2011

    Report

    Report Number
    3006630150-2011-00250
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING, PERFORMANCE AND ELECTRICAL TESTS PERFORMED. THE DEVICE OUTPUT WAS MONITORED FOR EXCESSIVE LEAKAGE CURRENT OR SPURIOUS SIGNALS IN A SALINE SOLUTION, WHILE PROGRAMMED TO THE PATIENT'S LATEST SETTING. NO DISCREPANCIES WERE IDENTIFIED. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE LEADS PASSED VISUAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE LEADS EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS FEELING 'JERKING SENSATION' IN HER CERVICAL IMPLANT. DURING A LEAD REVISION SURGERY THE PATIENT REPORTED DISCOMFORT AT THE BATTERY SITE. THE PHYSICIAN EXPLANTED THE WHOLE PRECISION SYSTEM AS THE IMPEDANCES WERE SHOWING REALLY LOW. THE PATIENT IS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS FEELING 'JERKING SENSATION' IN HER CERVICAL IMPLANT. DURING A LEAD REVISION SURGERY THE PATIENT REPORTED DISCOMFORT AT THE BATTERY SITE. THE PHYSICIAN EXPLANTED THE WHOLE PRECISION SYSTEM AS THE IMPEDANCES WERE SHOWING REALLY LOW. THE PATIENT IS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014" STYLET| MODEL# SC-2218-70, SERIAL# (B)(4)| IPG KIT (WITHOUT PULL-THROUGH TUNNELER):| MODEL# SC-1110-02, SERIAL# (B)(4)