BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 4103311 · Received September 19, 2014

    Report

    Report Number
    1644487-2014-02414
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE GENERATOR; HOWEVER, THIS IS ACTUALLY THE LEAD. TYPE OF DEVICE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE GENERATOR; HOWEVER, THIS IS ACTUALLY THE LEAD. MODEL #, SERIAL #, LOT #, EXPIRATION DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE GENERATOR; HOWEVER, THIS IS ACTUALLY THE LEAD. DEVICE MANUFACTURE DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE GENERATOR; HOWEVER, THIS IS ACTUALLY THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INCISION AND DRAINAGE OF A LEFT SCAPULAR ABCESS AND COMPLETE REMOVAL OF THE VNS SYSTEM. BOTH LEAD AND GENERATOR WERE EXPLANTED. THE EXPLANTED DEVICES WERE RETURNED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE LEAD WAS COMPLETED ON 09/22/2014. MULTIPLE BREAKS WERE CONFIRMED IN THE NEGATIVE COIL OF THE RETURNED LEAD PORTIONS. MFR. REPORT # 1644487-2014-02711 WILL HOUSE THE LEAD ANALYSIS. ANALYSIS OF THE GENERATOR WAS COMPLETED ON 09/25/2014. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE.

    Description of Event or Problem · 1

    BASED ON THE INFORMATION AVAILABLE TO DATE, THE REPORTED LEFT SCAPULAR ABSCESS APPEARS TO BE THE RESULT OF LEAD DISSOLUTION: WHEN A LEAD FRACTURE OCCURS AND A SMALL LENGTH OF THE LEAD IS EXPOSED TO EXTRACELLULAR FLUID, THE BROKEN END OF THE LEAD ACTS AS THE ELECTRODE. THE CURRENT DELIVERED BY THE PULSE GENERATOR IS CONDUCTED THROUGH THE VERY SMALL SURFACE AREA OF THE FRACTURED LEAD. THE RESULT OF THIS EVENT IS THE PITTING AT THE BROKEN END OF THE COIL WIRE. ADVERSE EVENTS ASSOCIATED WITH THIS EVENT CAN INCLUDE INFECTION-LIKE SYMPTOMS INCLUDING INFLAMMATION, PAIN, OR EDEMA OF ABSCESS. THE ADVERSE EVENTS REPORTED HERE APPEAR TO BE THE RESULT OF THE LEAD MALFUNCTION REPORTED IN MFR REPORT #1644487-2014-02711.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583700 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1598

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention