BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 3241014 · Received July 18, 2013

    Report

    Report Number
    1627487-2013-16019
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 FELT INTERMITTENT STIMULATION. SHE STATED SHE DOES NOT DO ANY EXCESSIVE MOVEMENT THAT COULD CAUSE HER STIMULATION TO CHANGE. SHE REPORTED X-RAYS APPEARED TO SHOW HER LEAD WIRES WERE "TWISTED". THE PATIENT PLANS TO CONSULT WITH HER PHYSICIAN REGARDING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335202 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3434495

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR SCS IPG: MODEL 3788| IMPLANT DATE: