BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3041525 · Received April 8, 2013

    Report

    Report Number
    3006630150-2013-00585
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SC-2352-50 SN (B)(4): VISUAL AND X-RAY INSPECTION OF THE LEAD FOUND CABLES THAT WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. HIGH IMPEDANCE READINGS WERE REGISTERED AT CONTACTS # CONTACT 1, 3, 5, 7 AND 8. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT. SC-4316 LOT # 14304817: THE CLIK ANCHOR IS INTACT AND NO PARTS OF IT ARE MISSING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-4316 SERIAL/LOT # (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS RECEIVING INADEQUATE STIMULATION. A SYSTEM CHECK REVEALED HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN REPLACED THE LEAD. THE PHYSICIAN CHOSE TO ALSO REPLACE THE CLIK ANCHOR AS IT WAS CONNECTED TO THE LEAD. THE PATIENT WAS REPORTEDLY DOING WEL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS RECEIVING INADEQUATE STIMULATION. A SYSTEM CHECK REVEALED HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN REPLACED THE LEAD. THE PHYSICIAN CHOSE TO ALSO REPLACE THE CLIK ANCHOR AS IT WAS CONNECTED TO THE LEAD. THE PATIENT WAS REPORTEDLY DOING WEL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144027 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1