BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4123995 · Received September 27, 2014

    Report

    Report Number
    3006630150-2014-02212
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    July 28, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE IPG HAD MIGRATED AND WAS NOT IN A FLAT POSITION WHICH WAS CAUSING THE DISCOMFORT AND DIFFICULTY CHARGING. THE IPG WAS REPOSITIONED DEEPER INTO THE BUTTOCKS.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG AND HAD POCKET SITE DISCOMFORT. IT WAS ALSO REPORTED THAT THE IPG HAD APPARENTLY SETTLED HORIZONTALLY UNDER THE SKIN. THE PATIENT UNDERWENT AN IPG REVISION. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG AND HAD POCKET SITE DISCOMFORT. IT WAS ALSO REPORTED THAT THE IPG HAD APPARENTLY SETTLED HORIZONTALLY UNDER THE SKIN. THE PATIENT UNDERWENT AN IPG REVISION. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG AND HAD POCKET SITE DISCOMFORT. IT WAS ALSO REPORTED THAT THE IPG HAD APPARENTLY SETTLED HORIZONTALLY UNDER THE SKIN. THE PATIENT UNDERWENT AN IPG REVISION. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN¿S IMPLANT MANUAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603762 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention