BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 60-CM LENGTH PADDLE LEAD

    MDR report key: 2181331 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-03325
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    August 24, 2010
    Report Date
    June 22, 2011
    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 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 THE PENTA LEAD ON (B)(6) 2010 AS A RESULT OF RECEIVING STIMULATION IN THE WRONG AREA (REFER TO 1627487-2011-03324). HE STATED HE IS GETTING RIB AND ABDOMINAL STIMULATION. THE PT IS WORKING WITH HIS PHYSICIAN FOR A POTENTIAL REVISION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 60-CM LENGTH PADDLE LEAD SPINAL CORD SITMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3143272

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL: 3716| SCS ANCHOR, MODEL: 1194