BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESUME II OR RESUME TL

    MDR report key: 829958 · Received March 19, 2007

    Report

    Report Number
    2182207-2007-00951
    Event Type
    Injury
    Date Received
    March 19, 2007
    Report Date
    January 24, 2007
    Manufacturer
    MEDTRONIC, INC., NEUROLOGICAL DIVISION
    Product Code
    GZB
    PMA / PMN Number
    k884948
    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 LAMINOTOMY TYPE LEAD IMPLANTS WERE PRIMARILY RESUME II MODEL 3587A AND RESUME TL MODEL 3986A.

    Description of Event or Problem · 1

    THE ARTICLE LISTS THREE CASES OF INFECTION RELATED TO RESUME LEAD (CRPS). NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING PATIENT SYMPTOMS AND 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 RESUME II OR RESUME TL GZF/GZB OR LGW GZB MEDTRONIC, INC., NEUROLOGICAL DIVISION 3587A UNK

    Patients

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