BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3052345 · Received April 3, 2013

    Report

    Report Number
    1627487-2013-04404
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    October 12, 2012
    Report Date
    March 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 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

    IT WAS REPORTED THE PATIENT HAD CONTACTED THE SJM REPRESENTATIVE DUE TO HOSPITALIZATION AFTER THE IMPLANT OF THE SCS SYSTEM. THE PATIENT REPORTED SHE HAD PULMONARY SYMPTOMS POSTOPERATIVE AND HAD BEEN GIVEN A TRACHEOSTOMY. IT WAS REPORTED THE PATIENT HAD RESPIRATORY DISTRESS DUE TO THE ANESTHESIA POSTOPERATIVE. IT WAS REPORTED THE PATIENT HAD RECEIVED A HALO FOR THE CERVICAL PLACEMENT OF THE LEAD WHICH MAY HAVE CAUSED A POSITIONAL ISSUE. THE PATIENT WAS PLACED IN A LONG TERM FACILITY FOR RECOVERY, AND HAS SINCE BEEN RELEASED AND IS AT HOME. IT WAS REPORTED THE PATIENT WAS CURRENTLY STABLE, AND WAS RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137539 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3789188

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O| R IMPLANT:| SCS IPG: MODEL 3788| IMPLANT:| SCS EXTENSION: MODEL 3383 (2)