BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIPOLE 16-CM LENGTH PADDLE LEAD

    MDR report key: 2193082 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-03313
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 AN SCS SYS ON (B)(6) 2011. IT WAS REPORTED THAT THE PT FELT A SUDDEN SURGE OF STIMULATION AT THE INCISION SITE WHEN HE TURNS THE STIMULATION OFF OR CHANGES PROGRAMS. ATTEMPTS TO MEET WITH THE REP FOR REPROGRAMMING HAVE BEEN UNSUCCESSFUL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPOLE 16-CM LENGTH PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3350866

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1194 (2)| IMPLANT:| IMPLANT: