BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3223200 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-06586
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    August 15, 2012
    Report Date
    June 14, 2013
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    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

    IT WAS REPORTED THE PATIENT EXPERIENCED A FALL AND SINCE SHE HAS BEEN UNABLE TO INCREASE HER STIMULATION AMPLITUDE. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND A DIAGNOSTIC OF THE SCS LEAD REVEALED HIGH IMPEDANCE FOR TWO OF THE LEAD CONTACTS. THE REPRESENTATIVE WAS ABLE TO REPROGRAM THE SYSTEM AND GAVE THE PATIENT NEW PROGRAMS TO TRY. FOLLOW-UP IDENTIFIED THE REPROGRAMMING WORKED TEMPORALLY, HOWEVER, THE PATIENT IS NOW NOT RECEIVING EFFECTIVE STIMULATION. X-RAYS WILL BE ORDERED TO DETERMINE IF THE SYSTEM WAS COMPROMISED BY THE PATIENT FALLING. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316130 PENTA SCS LEAD LGW ST. JUDE MEDICAL, NEUROMODULATION 3228 3479495

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other SCS IPG: MODEL 3688| IMPLANT DATE: