BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4222309 · Received November 4, 2014

    Report

    Report Number
    3006630150-2014-02530
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT'S SYMPTOMS ALSO INCLUDED BLEEDING AND OOZING PUS AT THE POCKET SITE. THE PATIENT'S IPG WILL BE TAKEN OUT SINCE THE INCISION SITE WAS NOT HEALING AND KEPT ON OPENING UP.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT EXPLANT. THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S POCKET SITE OPENED AND PUS WAS COMING OUT. THE PHYSICIAN CONFIRMED IT WAS AN INFECTION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE POCKET SITE WAS FLUSHED AND RE-STITCHED. IT WAS STATED THAT THE INFECTION WAS FROM THE WOUND BEING OPENED BY PATIENT¿S OVERDOING ACTIVITY. THE PATIENT WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S POCKET SITE OPENED AND PUS WAS COMING OUT. THE PHYSICIAN CONFIRMED IT WAS AN INFECTION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE POCKET SITE WAS FLUSHED AND RE-STITCHED. IT WAS STATED THAT THE INFECTION WAS FROM THE WOUND BEING OPENED BY PATIENT¿S OVERDOING ACTIVITY. THE PATIENT WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S POCKET SITE OPENED AND PUS WAS COMING OUT. THE PHYSICIAN CONFIRMED IT WAS AN INFECTION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE POCKET SITE WAS FLUSHED AND RE-STITCHED. IT WAS STATED THAT THE INFECTION WAS FROM THE WOUND BEING OPENED BY PATIENT¿S OVERDOING ACTIVITY. THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707663 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention