BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2895652 · Received January 3, 2013

    Report

    Report Number
    3006630150-2013-00001
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN REMOVED THE DISLODGED CONTACT FROM THE PATIENT'S BODY DURING THE REVISION.

    Additional Manufacturer Narrative · 1

    THE LEAD PASSED MECHANICAL TESTS PERFORMED. THE COMPLAINT HAS BEEN CONFIRMED. VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD FOUND BROKEN CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. HIGH IMPEDANCE READINGS WERE REGISTERED AT CONTACTS # 2, 3 AND 8. THIS LOCATION APPEARS TO BE THE SITE WHERE THE SUTURE SLEEVE WAS POSITIONED. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT. THE LEAD IS INTACT AND NO PARTS OF IT ARE MISSING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS RECEIVING INADEQUATE PAIN RELIEF. IT WAS NOTED THAT THE PERCUTANEOUS LEAD DISPLAYED THREE CONTACTS WITH HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION AND THE PHYSICIAN NOTED THAT A CONTACT FELL OFF. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS RECEIVING INADEQUATE PAIN RELIEF. IT WAS NOTED THAT THE PERCUTANEOUS LEAD DISPLAYED THREE CONTACTS WITH HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION AND THE PHYSICIAN NOTED THAT A CONTACT FELL OFF. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS RECEIVING INADEQUATE PAIN RELIEF. IT WAS NOTED THAT THE PERCUTANEOUS LEAD DISPLAYED THREE CONTACTS WITH HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION AND THE PHYSICIAN NOTED THAT A CONTACT FELL OFF. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3189 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R