BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 5965471 · Received September 20, 2016

    Report

    Report Number
    3006630150-2016-02664
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    August 30, 2016
    Report Date
    August 30, 2016
    Manufacturer
    LGW
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS UNKNOWN IF THE MISSING SILICONE WAS REMOVED FROM THE PATIENT'S BODY.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-1110-02 SERIAL #: (B)(4) DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG) MODEL#: SC-3400-30 SERIAL #: (B)(4) DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM) MODEL#: SC-4316 LOT #: 15418724 DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS PHYSICIAN'S PREFERENCE TO EXPLANT THE PATIENT. NO DEVICE MALFUNCTION WAS SUSPECTED. SC-2316-50 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE COMPLAINT WAS CONFIRMED. THE LEAD BODY WAS CUT AND THE PROXIMAL TIP WAS NOT RETURNED. HOWEVER, MOST CABLES WERE FRACTURED AT THE KINKED SECTIONS OF THE LEAD BODY WHERE A CLIK ANCHORED ABOUT 18 CM FROM THE DISTAL TIP. THE CABLES WERE NOT EXPOSED. SC-4316 (LN 15418724) DEVICE EVALUATION INDICATED THAT THE COMPLAINT WAS CONFIRMED. SILICONE MATERIAL WAS MISSING FROM ONE OF THE EYELETS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION. HIGH IMPEDANCES WERE NOTED ON THE LEAD. IT WAS REPORTED A LEAD WAS REPORTEDLY DAMAGED. THE PATIENT UNDERWENT A REVISION A PROCEDURE WHERE IN THE LEAD, CLIK ANCHOR AND SPLITTER AND THE IPG WERE REPLACED DUE TO PHYSICIAN¿S REQUEST AND MALFUNCTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION. HIGH IMPEDANCES WERE NOTED ON THE LEAD. IT WAS REPORTED A LEAD WAS REPORTEDLY DAMAGED. THE PATIENT UNDERWENT A REVISION A PROCEDURE WHERE IN THE LEAD, CLIK ANCHOR AND SPLITTER AND THE IPG WERE REPLACED DUE TO PHYSICIAN'S REQUEST AND MALFUNCTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION. HIGH IMPEDANCES WERE NOTED ON THE LEAD. IT WAS REPORTED A LEAD WAS REPORTEDLY DAMAGED. THE PATIENT UNDERWENT A REVISION A PROCEDURE WHERE IN THE LEAD, CLIK ANCHOR AND SPLITTER AND THE IPG WERE REPLACED DUE TO PHYSICIAN'S REQUEST AND MALFUNCTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614188 PRECISION® SPINAL CORD STIMULATOR LGW LGW SC-2316-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR