BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2090412 · Received May 16, 2011

    Report

    Report Number
    3006630150-2011-00709
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HAS BEEN CONFIRMED. VISUAL INSPECTION REVEALED THAT THE PADDLE WAS SEVERELY DAMAGED AND ALL OF ITS CONTACTS ARE DISLODGED. IT WAS REPORTED THAT THE PATIENT WAS LIFTING WEIGHTS. THE PHYSICIAN AND PATIENT BELIEVED THAT IT WAS THE ROOT CAUSE OF THE LEAD FRACTURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PADDLE LEAD WAS IN PIECES AND THE CONTACTS HAVE DETACHED FROM THE LEAD. THE PHYSICIAN EXPLANTED THE PADDLE LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PADDLE LEAD WAS IN PIECES AND THE CONTACTS HAVE DETACHED FROM THE LEAD. THE PHYSICIAN EXPLANTED THE PADDLE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention