BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1151346 · Received September 4, 2008

    Report

    Report Number
    2029203-2008-00568
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP.
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED MATERIALS WILL NOT BE RETURNED FOR EVALUATION, AS THEY WERE KEPT BY THE PATIENT. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    DURING THE LEAD REVISION PROCEDURE, THE SURGEON HAD DIFFICULTY REMOVING ONE OF THE LEADS DUE TO SCAR TISSUE. THE SURGEON CUT THE LEAD AND THE REMAINING PORTION WAS LEFT IMPLANTED IN THE PATIENT. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP. SC-2138-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LINEAR LEAD (PHASE IIIA)