BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD

    MDR report key: 1936245 · Received December 14, 2010

    Report

    Report Number
    1627487-2010-03926
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 15, 2010
    Manufacturer
    SJM NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT RECEIVED HIS SCS SYS ON (B)(6) 2004. IT WAS REPORTED THAT THE PT COULD NOT FEEL STIMULATION. THE PT MET WITH A COMPANY REP AND WAS TOLD THAT 12 OF 16 CONTACTS EXHIBITED INVALID IMPEDANCES. HE WAS REPROGRAMMED AND FELT SOME PAIN RELIEF, BUT LOST STIMULATION AGAIN ON (B)(6) 2010. THE PT IS SCHEDULED TO MEET WITH A COMPANY REP AGAIN. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD SPINAL CORD STIMULATION LEAD LGW SJM NEUROMODULATION DIVISION 22086

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention