BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIPOLE 60-CM PADDLE LEAD

    MDR report key: 2210402 · Received August 9, 2011

    Report

    Report Number
    1627487-2011-04019
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 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 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 SYSTEM, INCLUDING IPG AND SCS LEAD ON (B)(6) 2011. THE PT WAS EXPLANTED DUE TO WEAKNESS IN THE LEGS, AND EPIDURAL HEMATOMA. THE SYSTEM WAS DISCARDED. IT WAS REPORTED THAT THE PHYSICIAN CUT THE TIP OF THE LEAD FOR SHAPING. IN THE PHYSICIAN'S OPINION, THE SYMPTOMS ARE NOT DEVICE RELATED. THE NEXT COURSE OF ACTION IS FOR THE PT TO UNDERGO PHYSICAL THERAPY. THE STATUS OF PT HAS BEEN REPORTED AS PARTIALLY RESOLVED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPOLE 60-CM PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3376712

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R IMPLANT DATE:| SCS IPG: MODEL 3788