BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3930037 · Received July 11, 2014

    Report

    Report Number
    3006630150-2014-01581
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOCATION OF THE INFECTION WAS AT THE BACK OF THE PATIENT¿S HEAD. THE PATIENT UNDERWENT A REVISION WHEREIN THE ENTIRE SCS SYSTEM WAS EXPLANTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-1132, SERIAL #: (B)(4), DESCRIPTION: PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR THE REVISION WAS INFECTION. SYMPTOMS INCLUDED REDNESS AND SWELLING. THE PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS. THE PHYSICIAN BELIEVED THE INFECTION WAS NOT RELATED TO THE STIMULATOR.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL BE HAVING LEAD REVISION. THE REASON FOR REVISION WAS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL BE HAVING LEAD REVISION. THE REASON FOR REVISION WAS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL BE HAVING LEAD REVISION. THE REASON FOR REVISION WAS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL BE HAVING LEAD REVISION. THE REASON FOR REVISION WAS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL BE HAVING LEAD REVISION. THE REASON FOR REVISION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407527 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention