BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 30 CM

    MDR report key: 2542551 · Received April 13, 2012

    Report

    Report Number
    1627487-2012-08708
    Event Type
    Injury
    Date Received
    April 13, 2012
    Date of Event
    August 26, 2011
    Report Date
    March 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 THE SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT WAS UNABLE TO GET STIMULATION ON THE CORRECT BODY AREA. THE LEAD HAD MIGRATED. THE LEAD WILL BE REVISED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. DEVICE 2 OF 4. REFERENCE MFR REPORTS: 1627487-2011-08289, 1627487-2012-087, 1627487-2012-08710.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD WIDE SPACED, 30 CM SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3163 3250341

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SCS IPG: MODEL 3788| IMPLANTED: