BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3162264 · Received June 11, 2013

    Report

    Report Number
    3006630150-2013-01166
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO A REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2352-70, SERIAL / LOT # (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A SENSATION OF TIGHTNESS AND PRESSURE AT THE LEAD SITE. THE PHYSICIAN HOPES THAT THE LEAD WILL LOOSEN ON ITS OWN, HOWEVER, A REVISION HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A SENSATION OF TIGHTNESS AND PRESSURE AT THE LEAD SITE. THE PHYSICIAN HOPES THAT THE LEAD WILL LOOSEN ON ITS OWN, HOWEVER, A REVISION HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262128 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention