BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD

    MDR report key: 829938 · Received March 19, 2007

    Report

    Report Number
    2182207-2007-00948
    Event Type
    Injury
    Date Received
    March 19, 2007
    Report Date
    January 24, 2007
    Manufacturer
    MEDTRONIC IND, NEUROLOGICAL DIVISION
    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 THE PERCUTANEOUSLY INSERTED LEAD IMPLANTS WERE PRIMARILY PISCES-QUAD MODEL 3887 AND PISCES-QUAD MODEL 3888.

    Description of Event or Problem · 1

    THE ARTICLE LISTS FOUR CASES OF PERCUTANEOUS LEAD BREAKAGE (FBBS). 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 LEAD P840001 LGW MEDTRONIC IND, NEUROLOGICAL DIVISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R IMPLANTABLE PULSE GENERATOR