BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3822251 · Received May 20, 2014

    Report

    Report Number
    3006630150-2014-01128
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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-4316, LOT #: 14682195, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE; MODEL#: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT OF HIGH IMPEDANCE WAS NOT CONFIRMED AS VARIOUS TEST LEADS WERE INSERTED IN BOTH PORTS. ALL IMPEDANCE READINGS WERE WITHIN NORMAL RANGE. HIGH IMPEDANCE READINGS COULD NOT BE DUPLICATED IN THE LAB. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. SC-2218-50 SN (B)(4): THE COMPLAINT HAS BEEN CONFIRMED. VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT/KINKED LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE. SC-4316 THE CLIK ANCHORS ARE INTACT AND NO PARTS OF IT ARE MISSING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD LOSS OF STIMULATION. DATABASE ANALYSIS REVEALED THAT SEVERAL CONTACTS OF THE LEADS WERE SHOWING HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN HAD SUSPECTED DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD LOSS OF STIMULATION. DATABASE ANALYSIS REVEALED THAT SEVERAL CONTACTS OF THE LEADS WERE SHOWING HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN HAD SUSPECTED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300692 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR