BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA LEAD KIT, 60CM LENGTH

    MDR report key: 1924665 · Received December 7, 2010

    Report

    Report Number
    1627487-2010-03905
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 8, 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
    MI, 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT WHEN STIMULATION IS TURNED UP, HE CAN FEEL IT IN HIS STERNUM. THE PATIENT WAS REPROGRAMMED ON (B)(6) 2010 AND THE SITUATION WILL BE REASSESSED IN ONE WEEK. THE LEAD WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    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 3121550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention