BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 3113303 · Received April 26, 2013

    Report

    Report Number
    1627487-2013-03563
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    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 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

    IT WAS REPORTED LEAD DIAGNOSTICS SHOWED INVALID IMPEDANCE VALUES FOR THE SCS LEAD DURING THE PERMANENT PROCEDURE AFTER THE LEAD WAS SUTURED. SUBSEQUENTLY, THE PHYSICIAN UNHOOKED THE LEAD TAILS FROM THE SCS IPG, AND RECONNECTED TO NO AVAIL. FURTHERMORE, THE PHYSICIAN THEN CUT THE SUTURE AND THE CONTACTS BECAME VALID, SO CINCH ANCHORS WERE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180739 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3860321

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL: 1194 (2)| SCS IPG: MODEL: 3788