BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3120397 · Received May 20, 2013

    Report

    Report Number
    1644487-2013-01211
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THERE WAS NO KNOWN RELATIONSHIP OF THEIR EVENTS TO ANY PATIENT MANIPULATION OR TRAUMA. UNKNOWN RELATIONSHIP TO THEIR VNS DEVICE. THE PATIENT'S EXPLANTED GENERATOR WAS RETURNED FOR ANALYSIS AND PENDING COMPLETION. CULTURES WERE TAKEN ON (B)(6) 2013 FROM CHEST SITE. FEW STAPHYLOCOCCUS AND RARE STAPHYLOCOCCUS SPECIES COAGULASE NEGATIVE. IT WAS REPORTED THAT THEIR POCKET FAILED TO HEAL.

    Description of Event or Problem · 1

    ON (B)(4) 2013 PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. RESULTS OF DIAGNOSTIC TESTING INDICATED THE DEVICE WAS OPERATING PROPERLY AND COMMUNICATED PROPERLY. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES THAT A VNS PATIENT WAS HAVING DIFFICULTIES WITH THEIR VNS POCKET. THEY HAD A BATTERY REPLACEMENT (B)(6) 2013 AND AT THAT TIME THEIR VNS POCKET WAS REVISED. THEIR SUTURES WERE REMOVED. SHE THEN EXPERIENCED DEHISCENCE OF THEIR MORE SUPERIOR WOUND AND GENERATOR MIGRATION OF THEIR GENERATOR TO THE SURFACE. IT WAS GRANULATING. THE PATIENT WAS SCHEDULED FOR , INCISION, DRAINAGE, DEBRIDEMENT AND CLOSURE OF THE LEFT CHEST WOUND. THE PATIENT HAD A WOUND DEBRIDEMENT AND INCISION AND DRAINAGE ON (B)(6). THE SUPERIOR WOUND WAS DEBRIDED OF GRANULATION TISSUE. THE INFERIOR WOUND HAD A SMALL SOFT AREA IN THE MIDDLE. IT APPEARED THAT THERE WAS A CONNECTION SUBCUTANEOUSLY BETWEEN THE TWO WOUNDS WITH SOME FLUID PRESENT. THIS WAS EVACUATED. A SMALL AREA OF ATROPIC SKIN WAS INFERIORLY EXCISED. COPIOUS BACITRACIN IRRIGATION WAS USED PRIOR TO CLOSURE. THE PATIENT WAS SEEN FOR THEIR POSTOP VISIT ON (B)(6) AND THEIR INCISION WAS INTACT. THERE WAS SOME SEROSANGUINOUS DRAINAGE LIKELY FROM REMOVAL OF THEIR GRANULATED TISSUE. THE PATIENT WAS PUT ON KEFLEX PROPHYLACTICALLY AND WAS TO BE SEEN AGAIN ON (B)(6) FOR FOLLOWUP AND TO DECIDE NEXT PLAN OF CARE. THE PATIENT THOUGHT HER SKIN INCISION LOOKED THIN AND WAS CONCERNED ABOUT OPENING. ON (B)(6) THE PATIENT'S GENERATOR WAS REMOVED AND IT WAS DECIDED TO LET THEIR POCKET HEAL PRIOR TO GENERATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222523 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 202283

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention