BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2011648 · Received March 9, 2011

    Report

    Report Number
    3006630150-2011-00345
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION STATED THAT THE PATIENT UNDERWENT A REVISION. THE PHYSICIAN PLUGGED THE LEAD BACK INTO THE IPG. NOTHING WAS IMPLANTED OR EXPLANTED AND THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WILL UNDERGO A LEAD AND POCKET REVISION FROM SKIN SENSITIVITY AT THE IPG SITE. THE PATIENT HAD FALLEN ON ICE AND TWISTED HER TRUNK AND SINCE THE FALL, THE PATIENT HAS BEEN EXTREMELY SENSITIVE TO THE TOUCH AT THE IPG LOCATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WILL UNDERGO A LEAD AND POCKET REVISION FROM SKIN SENSITIVITY AT THE IPG SITE. THE PATIENT HAD FALLEN ON ICE AND TWISTED HER TRUNK AND SINCE THE FALL, THE PATIENT HAS BEEN EXTREMELY SENSITIVE TO THE TOUCH AT THE IPG LOCATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention