BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2900187 · Received January 7, 2013

    Report

    Report Number
    3006630150-2013-00020
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT WHEN THE LEAD WAS EXPLANTED THE CLIK ANCHOR REMAINED ANCHORED TO THE LEAD. THE PHYSICIAN SUSPECTED THAT THE CLIK ANCHOR COULD BE INVOLVED WITH THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-4316 LOT: 14560667 DESCRIPTION: CLIK ANCHOR THE COMPLAINT WAS CONFIRMED. VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT SEVEN OF THE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE FRACTURE SITE WAS 1 CM FROM THE CLIK ANCHOR SETSCREW MARK. VISUAL INSPECTION OF THE CLIK ANCHOR REVEALED THAT THE EYELETS WERE TORN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD LOST STIMULATION. AN IMPEDANCE CHECK REVEALED ALL BUT ONE CONTACT WAS OUT WITH HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION, DURING WHICH, THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD LOST STIMULATION. AN IMPEDANCE CHECK REVEALED ALL BUT ONE CONTACT WAS OUT WITH HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION, DURING WHICH, THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD LOST STIMULATION. AN IMPEDANCE CHECK REVEALED ALL BUT ONE CONTACT WAS OUT WITH HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION, DURING WHICH, THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8161 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1