BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA LEAD KIT, 60CM LENGTH

    MDR report key: 1924679 · Received December 7, 2010

    Report

    Report Number
    1627487-2010-03904
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 8, 2010
    Manufacturer
    SJM NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT IN HER STOMACH AREA. FOLLOW UP ON THE PATIENT FOUND THAT THE ALLEGED PAIN HAS MOSTLY RESOLVED AND SHE IS VERY SATISFIED WITH THE STIMULATION. THE LEAD WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW SJM NEUROMODULATION 3228 3168012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention