BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2851504 · Received November 29, 2012

    Report

    Report Number
    3006630150-2012-02154
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A DISLODGED ELECTRODE WAS CONFIRMED. VISUAL INSPECTION REVEALED AN ELECTRODE WAS PARTIALLY DISLODGED FROM THE SILICONE, BUT THE CABLE WAS STILL ELECTRICALLY CONNECTED. ROOT CAUSE OF THE DISLODGED ELECTRODE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN ACROSS HER CHEST WHEN THE STIMULATION WAS ON. AN X-RAY REVEALED THAT THE PADDLE LEAD HAD FLIPPED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE PADDLE LEAD WAS REPLACED BECAUSE THE CONTACTS HAD POPPED OUT. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN ACROSS HER CHEST WHEN THE STIMULATION WAS ON. AN X-RAY REVEALED THAT THE PADDLE LEAD HAD FLIPPED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE PADDLE LEAD WAS REPLACED BECAUSE THE CONTACTS HAD POPPED OUT. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention