BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4091798 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-15628
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    THE PT HAS 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PT RECLINED IN A CHAIR AND AFTERWARDS BEGAN EXPERIENCING PAIN WHEN STIMULATION IS TURNED ON. THE SJM REP MET WITH THE PT AND IMPEDANCE VALUES WERE WITHIN NORMAL LIMITS, HOWEVER, PAINFUL STIMULATION CONTINUED TO OCCUR. X-RAYS WERE TAKEN AND INDICATED ONE LEAD HAD MIGRATED. REPROGRAMMING WAS UNABLE TO PROVIDE EFFECTIVE COVERAGE. THE PT WAS LATER INVOLVED IN A PHYSICAL ALTERCATION AND ADDITIONAL X-RAYS INDICATED BOTH LEADS HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 AND ONE LEAD WAS REPOSITIONED AND ONE LEAD WAS EXPLANTED AND REPLACED. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526145 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3153 4240095

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other SCS IPG: MODEL 3716| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3343| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)