BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPUSTIM RECEIVER

    MDR report key: 2820184 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-12413
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    July 17, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ST. JUDE MEDICAL - 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

    SJM 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

    IT WAS REPORTED THE PATIENT IS WITHOUT STIMULATION. REPORTEDLY THE TRANSMITTER IS UNABLE TO COMMUNICATE WITH THE RECEIVER. A TRANSMITTER, COMPATIBLE WITH THE RECEIVER, WAS SENT TO THE PATIENT. THE SJM REPRESENTATIVE REPORTED THE NEW TRANSMITTER COMMUNICATED WITH THE RECEIVER. THE REPRESENTATIVE REPROGRAMMED THE SYSTEM SEVERAL TIMES BUT WAS UNABLE TO ATTAIN STIMULATION COVERAGE FOR THE PATIENT. THE NEXT COURSE OF ACTION WAS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPUSTIM RECEIVER SCS RECEIVER LGW ST. JUDE MEDICAL - NEUROMODULATION MNR916 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention