BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2890808 · Received December 21, 2012

    Report

    Report Number
    1627487-2012-10692
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 7, 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
    PL
    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: 1627487-2012-10691. IT WAS REPORTED, THE PATIENT ((B)(6)) LOST STIMULATION. X-RAY ANALYSIS INDICATED THE SCS LEAD MAY HAVE MOVED. FURTHER INSPECTION REVEALED THE IPG HAD ALSO FLIPPED IN THE POCKET CAUSING THE LEAD WIRES TO TWIST. THE PHYSICIAN ELECTED TO PROCEED WITH SURGICAL INTERVENTION. THE LEAD WAS REPOSITIONED AND THE LEAD WIRES STRAIGHTENED. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE IPG WAS HANGING LOOSELY IN THE ABDOMINAL WALL AND REVISED THE IPG SITE. INTRA-OPERATIVE TESTING WAS PERFORMED AND ALL IMPEDANCE VALUES WERE WITHIN NORMAL RANGE. EFFECTIVE STIMULATION WAS ACHIEVED POST-OPERATIVELY. ALL DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention