BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA PADDLE LEAD

    MDR report key: 2210401 · Received August 9, 2011

    Report

    Report Number
    1627487-2011-05018
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K090907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 RECEIVED HIS SCS LEAD ON (B)(6) 2011. THE PT RECEIVED HIS SCS IPG ON (B)(6) 2011. IT WAS REPORTED THAT WHEN THE PT LIES DOWN THE STIMULATION BECOMES TOO STRONG. HE IS ABLE TO PARTIALLY LOWER THE AMPLITUDE, BUT NOT ENOUGH TO A COMFORTABLE LEVEL. THE STIMULATION IS COMFORTABLE WHEN HE IS SEATED OR STANDING. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3345990

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other IMPLANT:| SCS IPG: MODEL 3788