BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 2577584 · Received May 14, 2012

    Report

    Report Number
    1627487-2012-04687
    Event Type
    Injury
    Date Received
    May 14, 2012
    Date of Event
    July 13, 2011
    Report Date
    April 20, 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
    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 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-04688. THE STUDY PATIENT RECEIVED TWO ANCHORS WITH DIFFERENT LOT NUMBERS. IT WAS REPORTED, THE PATIENT HAD PAIN AT ONE OF THE ANCHOR SITES WHEN HE ROLLS OVER THE AREA AT NIGHT. THE PHYSICIAN PRESCRIBED LIDODERM PATCHES AND PRESCRIPTION PAIN MEDICINE. INITIALLY, THE PATIENT REPORTED THIS RESOLVED THE PAIN. FOLLOW UP IDENTIFIED THE PATIENT WAS STILL FEELING DISCOMFORT AND THE PHYSICIAN PRESCRIBED LIDODERM PATCHES AND A DIFFERENT TYPE OF PAIN MEDICINE. FURTHER FOLLOW UP FOUND THE ISSUE WAS NOT COMPLETELY RESOLVED, BUT WAS MANAGED WITH THE PREVIOUSLY DESCRIBED PRESCRIPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT-LOCK ANCHOR SCS ANCHOR LGW ST. JUDE MEDICAL - NEUROMODULATION 1192 3282484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT:| SCS IPG: MODEL 3788