BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2358861 · Received December 5, 2011

    Report

    Report Number
    3006630150-2011-01959
    Event Type
    Injury
    Date Received
    December 5, 2011
    Date of Event
    October 13, 2011
    Report Date
    November 10, 2011
    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 SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL: SC-2218-50, SERIAL: (B)(4), DESCRIPTION: ENH ST LD KIT, MODEL: SC-1110-02 SERIAL: 217988 DESCRIPTION: PRECISION IPG KIT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATES THAT THE PATIENT'S HEADACHES ARE GONE AND PATIENT IS WALKING FINE. PHYSICIAN SUSPECTS THAT PATIENT PROBABLY HAD DURAL IRRITATION FROM THE LEAD WHICH IS NOW RESOLVED. PATIENT WAS NOT PROVIDED ANY TREATMENT AND ISSUES RESOLVED OVERTIME. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING A LOT OF PAIN SINCE THE IMPLANT SURGERY. THE PATIENT WAS ALSO EXPERIENCING HEADACHES AND WEAKNESS IN THE LEGS. THE PATIENT WENT TO HER PHYSICIAN AND WAS GIVEN HEADACHE MEDICATION. THE PATIENT'S PHYSICIAN DOES NOT THINK THE HEADACHES ARE RELATED TO THE DEVICE BUT THINKS IT'S DURAL IRRITATION FROM THE PROCEDURE. THE PATIENT'S HEADACHES HAVE IMPROVED WITH MEDICATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING A LOT OF PAIN SINCE THE IMPLANT SURGERY. THE PATIENT WAS ALSO EXPERIENCING HEADACHES AND WEAKNESS IN THE LEGS. THE PATIENT WENT TO HER PHYSICIAN AND WAS GIVEN HEADACHE MEDICATION. THE PATIENT'S PHYSICIAN DOES NOT THINK THE HEADACHES ARE RELATED TO THE DEVICE BUT THINKS IT'S DURAL IRRITATION FROM THE PROCEDURE. THE PATIENT'S HEADACHES HAVE IMPROVED WITH MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention