BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD

    MDR report key: 829951 · Received March 19, 2007

    Report

    Report Number
    2182207-2007-00949
    Event Type
    Injury
    Date Received
    March 19, 2007
    Report Date
    January 24, 2007
    Manufacturer
    MEDTRONIC NEUROLOGICAL
    Product Code
    LGW
    PMA / PMN Number
    p840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE SPECIFIC DEVICES USED WERE NOT IDENTIFIED BY PATIENT/COMPLICATION, THE AUTHOR INDICATES THAT PERCUTANEOUSLY INSERTED LEAD IMPLANTS WERE PRIMARILY PISCES-QUAD MODEL 3887 AND PISCES-QUAD MODEL 3888.

    Description of Event or Problem · 1

    THE ARTICLE REPORTS SEVEN CASES OF INFECTION RELATED TO PERCUTANEOUS LEAD (CRPS). NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING PATIENT OUTCOMES. JOURNAL REFERENCE: ROSENOW, MD, ET AL. "FAILURE MODES OF SPINAL CORD STIMULATION HARDWARE." J. NEUROSURGERY: SPINE/VOLUME 5, 2006; 183-190.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD LGW LGW MEDTRONIC NEUROLOGICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IMPLANTABLE PULSE GENERATOR