BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3033657 · Received April 3, 2013

    Report

    Report Number
    3006630150-2013-00611
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 1, 2013
    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 SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S NUMBNESS HAD DECREASED. NO INTERVENTIONS WERE PROVIDED FOR THE NUMBNESS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. IT WAS FOUND OUT THAT DURING THE PROCEDURE THE LEAD PENETRATED AND GONE THROUGH THE PATIENT'S SPINAL CORD. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE BUT HAD NUMBNESS IN HER LEGS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG) THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER A REVISION PROCEDURE (MFR REPORT #: 3006630150-2013-00431), THE PATIENT HAD PAIN THAT WAS HIGHER THAN NORMAL. THE PATIENT WAS GIVEN A LOT OF MEDICATIONS TO RELIEVE THE PAIN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER A REVISION PROCEDURE (MFR REPORT #: 3006630150-2013-00431), THE PATIENT HAD PAIN THAT WAS HIGHER THAN NORMAL. THE PATIENT WAS GIVEN A LOT OF MEDICATIONS TO RELIEVE THE PAIN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER A REVISION PROCEDURE (MFR REPORT #: 3006630150-2013-00431), THE PATIENT HAD PAIN THAT WAS HIGHER THAN NORMAL. THE PATIENT WAS GIVEN A LOT OF MEDICATIONS TO RELIEVE THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136132 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention