BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA

    MDR report key: 6631051 · Received June 9, 2017

    Report

    Report Number
    3006630150-2017-02180
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    May 23, 2017
    Report Date
    May 23, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50 SERIAL #: (B)(4) DESCRIPTION: LINEAR ST LEAD, 50CM MODEL #: SC-1132 SERIAL #: 111548 DESCRIPTION: PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR THE IPG REPLACEMENT WAS BECAUSE THE PATIENT WANTED A MAGNETIC RESONANCE IMAGING (MRI) COMPATIBLE SYSTEM. SC-2218-50 (B)(4) THE COMPLAINT WAS CONFIRMED. THREE CABLES WERE FRACTURED AT THE KINKED SECTIONS OF THE LEAD BODY WHERE A CLIK ANCHORED, BUT NO CABLES WERE EXPOSED AT THE SITE. SC-2218-50 (B)(4) VISUAL/X-RAY INSPECTIONS AND CONTINUITY TEST WERE PERFORMED TO ENSURE THE DEVICE INTEGRITY. NO ANOMALIES WERE FOUND. SC-1132 (B)(4) DEVICE EVALUATION INDICATED THAT THE DEVICE PASSED ALL TESTS PERFORMED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING SUFFICIENT COVERAGE DUE TO HIGH IMPEDANCE. PHYSICIAN SUSPECTED MALFUNCTION ON ONE OF THE LEADS. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING SUFFICIENT COVERAGE DUE TO HIGH IMPEDANCE. PHYSICIAN SUSPECTED MALFUNCTION ON ONE OF THE LEADS. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413157 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR