BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2213895 · Received August 17, 2011

    Report

    Report Number
    1644487-2011-01884
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, ATTEMPTS WERE MADE TO THE VNS IMPLANTING SURGEON TO VERIFY IF NON-ABSORBABLE SUTURES WERE USED TO SECURE THE GENERATOR TO FASCIA DURING IMPLANTATION OF THE VNS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN THE SURGEON REPORTED THAT PERMANENT SUTURES (NEUROLON) ARE ALWAYS USED TO SECURE THE GENERATOR TO FASCIA DURING IMPLANTATION OF THE VNS.

    Description of Event or Problem · 1

    ON (B)(6), 2011 A VNS TREATING PHYSICIAN REPORTED THAT THE VNS PATIENT'S GENERATOR WAS GOING TO BE EXPLANTED DUE TO MIGRATION OF THE GENERATOR. THE PATIENT FEELS THAT IT IS MOVING AROUND IN HER CHEST. THE PHYSICIAN LATER REPORTED THAT THEY HAVE NOT OBSERVED THE MIGRATION BUT IT WAS FIRST REPORTED TO THEM BY THE PATIENT ON (B)(6), 2011. THE DEVICE HAS BEEN OFF FOR A YEAR AND THE PATIENT IS DOING WELL. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE MIGRATION. THE PHYSICIAN DOES NOT KNOW WHETHER A NON-ABSORBABLE SUTURE WAS USED TO SECURE THE GENERATOR TO FASCIA DURING IMPLANTATION OF THE DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, WHEN IT WAS DISCOVERED THAT THE VNS PATIENT WAS BEING REFERRED FOR REMOVAL OF THE VNS SYSTEM DUE TO THE DEVICE MOVING AROUND HER CHEST. THE PATIENT UNDERWENT EXPLANT OF THE GENERATOR AND LEAD ON (B)(6) 2012. THE EXPLANTED GENERATOR AND LEAD WERE RETURNED FOR PRODUCT ANALYSIS ON (B)(6) 2012 THAT IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE GENERATOR IN THE PA LAB CONCLUDED THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. PRODUCT ANALYSIS ON THE LEADS WAS COMPLETED ON (B)(6) 2012. A LARGE PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS WERE OBSERVED INSIDE THE OUTER SILICONE TUBING IN MOST AREAS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE GENERATOR IN THE PA LAB CONCLUDED THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. PRODUCT ANALYSIS ON THE LEADS WAS COMPLETED ON (B)(6) 2012. A LARGE PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS WERE OBSERVED INSIDE THE OUTER SILICONE TUBING IN MOST AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 12240

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention