BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2113488 · Received May 31, 2011

    Report

    Report Number
    1627487-2011-00739
    Event Type
    Injury
    Date Received
    May 31, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A SURGICAL LEAD ON (B)(6) 2011. THE PLACEMENT OF THE DEVICE ALLEGEDLY PROVED DIFFICULT DUE TO THE PRESENCE OF SCAR TISSUE. IT WAS REPORTED THAT THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION COVERAGE WITH THE NEW LEAD. A DIAGNOSTIC TEST WAS TAKEN; HOWEVER, NO IMPEDANCE ISSUES WERE OBSERVED. EFFORTS TO RESOLVE THIS MATTER VIA REPROGRAMMING HAVE PROVEN UNSUCCESSFUL. IN ADDITION, IT WAS REPORTED THAT THE PATIENT HAS A LOW-GRADE FEVER. FOLLOW-UP ON THIS MATTER FOUND THAT THE REPORTED FEVER HAS SUBSIDED. THE PATIENT IS CURRENTLY WORKING WITH HER IMPLANTING PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION IN THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3334170

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: