BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3120057 · Received May 20, 2013

    Report

    Report Number
    1644487-2013-01472
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ATTEMPTS FOR THE PRODUCT RETURN FOUND THAT THE EXPLANTED DEVICE WAS THROWN AWAY, SO IT WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON'S OFFICE THAT THE PATIENT HAS BEEN RUBBING HIS DEVICE SITE AND THE GENERATOR IS NOW EXTRUDING FROM THE SKIN. THE DEVICE WAS SHOWING FROM A HOLE IN THE PATIENT'S SKIN, WHICH WAS APPROXIMATELY 1 CM IN SIZE. THE SURGEON PLANNED TO REMOVE THE PATIENT'S VNS GENERATOR AND SAVE THE LEADS. HE PLANNED TO MAKE A NEW INCISION, EVALUATE LEAD POSITION, UNSCREW THE LEADS FROM THE GENERATOR, AND THEN TUNNEL OVER THE SHOULDER AND PLACE A NEW VNS GENERATOR INTRACAPSULAR. THE OLD VNS GENERATOR WOULD BE REMOVED, AND THE PATIENT WOULD BE PLACED ON LONG TERM ANTIBIOTICS. SURGERY TOOK PLACE ON (B)(6) 2013. FOLLOW UP WITH THE SURGEON'S OFFICE FOUND THAT THE PATIENT WAS SEEN ON (B)(6) 2013; HOWEVER, THE PATIENT'S MOTHER HAD INITIALLY CALLED ABOUT THE INCIDENT TWO DAYS PRIOR, SO THE EVENT WAS FIRST OBSERVED ON (B)(6) 2013. THE VNS GENERATOR WAS REMOVED FROM THE LEFT ANTERIOR CHEST DURING SURGERY AND WAS FOUND TO STILL BE FUNCTIONING. A NEW GENERATOR WAS IMPLANTED IN THE PATIENT'S BACK SO THAT HE WOULD AVOID ANY MORE PATIENT MANIPULATION AND TRAUMA. PER THE NURSE, THE EXTRUSION WAS CAUSED BY THE PATIENT RUBBING THE AREA. IT WAS STATED THAT THE PATIENT'S MOTHER CONFIRMED THIS. IN ADDITION TO THE SURGERY, THE PATIENT WAS GIVEN ANTIBIOTICS FOR INTERVENTION. CULTURES WERE TAKEN; HOWEVER, THEY NEVER GREW ANYTHING. NO OTHER INFORMATION WAS PROVIDED. THE EXPLANTED DEVICE HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222154 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102 2703

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR