BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE 30-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2182218 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-03223
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2011-03222. THE PT RECEIVED A SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT'S IPG HAS FLIPPED AND PERIPHERAL LEAD HAS MIGRATED. THE PT STILL HAS STIMULATION. THE PHYSICIAN HAD BEEN NOTIFIED FOR POSSIBLE REVISION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE 30-CM LENGTH PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3163 3175192

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SCS LEAD: MODEL 3245| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE: