BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3103282 · Received May 9, 2013

    Report

    Report Number
    3006630150-2013-00937
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD STILL ISSUES WITH THE POCKET PAIN AND INJECTION WILL BE GIVEN WHEN NEEDED. THE REPORTED PAIN AT THE POCKET SITE WAS THE PRE-EXISTING PAIN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD PAIN AT THE POCKET SITE WHEN THE STIMULATION WAS ON OR OFF. THE PAIN WOULD ALSO EXACERBATE DURING CHARGING. THE PATIENT WAS GIVEN WITH EPIDURAL STEROID INJECTIONS AROUND THE SITE, AND THE PAIN WAS RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD PAIN AT THE POCKET SITE WHEN THE STIMULATION WAS ON OR OFF. THE PAIN WOULD ALSO EXACERBATE DURING CHARGING. THE PATIENT WAS GIVEN WITH EPIDURAL STEROID INJECTIONS AROUND THE SITE, AND THE PAIN WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203577 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention