BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1970418 · Received January 17, 2011

    Report

    Report Number
    3006630150-2011-00058
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS OF THE PADDLE LEAD REVEALED BROKEN AND OXIDIZED CABLES. A VISUAL INSPECTION OF THE PADDLE LEAD REVEALED THAT BOTH THE LEAD BODIES ENDS WERE SEPARATED FROM THE PADDLE AND BROKEN OR CUT APPROXIMATELY 13.5 INCH FROM THE PROXIMAL END. FURTHER INSPECTION REVEALED THAT THE RIGHT LEAD BODY HAD THREE AND LEFT LEAD BODY HAD TWO OXIDIZED CABLES. THE PADDLE END HAD THREE PARTIALLY DISLODGED ELECTRODES (6L, 7L AND 7R). THEY WERE STILL ATTACHED TO THE LEAD. THE EXPOSED CABLES OF THE PADDLE ALSO REVEALED OXIDIZED CABLES. THE OXIDIZED CABLES ARE INDICATIVE OF THE FACT THAT THE PADDLE WAS BROKEN INSIDE THE BODY. THE ROOT CAUSE FOR THIS BREAKAGE COULD NOT BE DETERMINED. THE RETURNED IPG SHOWED NORMAL DEVICE CHARACTERISTICS AND SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION SURGERY FOR INADEQUATE THERAPY, THE PHYSICIAN NOTICED THAT THE PT'S LEAD WAS BROKEN. THE PHYSICIAN WAS NOT SURE IF THIS WAS CAUSED BY THE PROCEDURE OR PREVIOUSLY. THE PHYSICIAN EXPLANTED THE SCS SYSTEM AND IMPLANTED TWO NEW SYSTEMS. THE PT WAS REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION SURGERY FOR INADEQUATE THERAPY THE PHYSICIAN NOTICED THAT THE PATIENT'S LEAD WAS BROKEN. THE PHYSICIAN WAS NOT SURE IF THIS WAS CAUSED BY THE PROCEDURE OR PREVIOUSLY. THE PHYSICIAN EXPLANTED THE SCS SYSTEM AND IMPLANTED TWO NEW SYSTEMS. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention MODEL#: SC-1110| (B)(4)| IMPLANTABLE PULSE GENERATOR (IPG)