BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1400812 · Received June 11, 2009

    Report

    Report Number
    2029203-2009-00886
    Event Type
    Injury
    Date Received
    June 11, 2009
    Date of Event
    June 27, 2006
    Report Date
    June 27, 2006
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE. DEVICE WAS EXPLANTED. THE RETURNED PRODUCT ANALYSIS FOR THE SC-2135-50 SCS LEAD CONCLUDED THAT THE PROXIMAL END HAD TWO-FRACTURED SPACERS. THE LEAD FAILED ELECTRICAL TEST DUE TO THE FRACTURES AT THE PROXIMAL END. THE LEAD WAS DAMAGED DURING THE REVISION WITH THE PATIENT. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION, THE PHYSICIAN EXPLANTED AND REPLACED A LEAD. THE LEAD WAS DAMAGED WHILE PLACING IN THE PATIENT. THE PATIENT IS REPORTEDLY DOING FINE AFTER THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMUALTOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2138-50

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention