BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60-CM LENGTH PENTA LEAD

    MDR report key: 2260167 · Received August 25, 2011

    Report

    Report Number
    1627487-2011-07151
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT 1627487-2011-07142. THE PT RECEIVED A SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED ON (B)(6) 2011 THAT WHEN THE PT TURNS STIMULATION UP, SOMETIMES THE STIMULATION WILL LOWER OR TURN ALL THE WAY OFF. WHEN SHE CONNECTS WITH THE PT PROGRAMMER (PP) THE STIMULATION MIGHT BE AT ZERO OR LOWER THAN WHAT IT WAS PREVIOUSLY SET AT. TESTING ALSO SHOWS THE LEAD HAS HIGH IMPEDANCE CONTACTS. A REPROGRAMMING SESSION IS BEING SCHEDULED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60-CM LENGTH PENTA LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3334170

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention