BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 2896171 · Received December 10, 2012

    Report

    Report Number
    1627487-2012-02801
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    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

    THE PATIENT'S LEAD WAS REVISED DUE TO LEAD MIGRATION ON (B)(6) 2012 (REFERENCE MFR REPORT #1627487-2012-012611). IT WAS REPORTED THE PATIENT WAS UNABLE TO FEEL STIMULATION AND REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. DIAGNOSTIC TESTING REVEALED LOW IMPEDANCE READINGS ON ALL LEAD CONTACTS EXCEPT FOR ONE WHICH EXHIBITED AN INVALID IMPEDANCE READING. AN X-RAY REVEALED THE CERVICAL LEAD HAD NOT MIGRATED SINCE THE REVISION ON (B)(6) 2012. THE PHYSICIAN STATED THE LEAD MAY NEED TO BE EXPLANTED AND REPLACED WITH PERCUTANEOUS LEADS TO ADDRESS THIS ISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3741496

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR SCS EXTENSION: MODEL 3386 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788