BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3130606 · Received May 24, 2013

    Report

    Report Number
    3006630150-2013-01056
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S WHITE BLOOD CELL COUNT AND C-REATIVE PROTEIN WERE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG POCKET SITE. THE PATIENT¿S SYMPTOM WAS SERIC NON-PURULENT LIQUID AT THE POCKET SITE. THE PHYSICIAN ASSESSED THAT THE INFECTION WAS PROCEDURE RELATED. THE PATIENT WAS ADMINISTERED AUGMENTIN AND CIPROFLOXACYNE ORAL ANTIBIOTICS AND WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG POCKET SITE. THE PATIENT¿S SYMPTOM WAS SERIC NON-PURULENT LIQUID AT THE POCKET SITE. THE PHYSICIAN ASSESSED THAT THE INFECTION WAS PROCEDURE RELATED. THE PATIENT WAS ADMINISTERED AUGMENTIN AND CIPROFLOXACIN ORAL ANTIBIOTICS AND WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232192 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention