BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2993042 · Received March 7, 2013

    Report

    Report Number
    1644487-2013-00626
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    November 30, 2012
    Report Date
    February 15, 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

    DATE RECEIVED BY MANUFACTURER (MO/DAY/YR) - CORRECTED DATA; SUPPLEMENTAL 01 SENT WITH INCORRECT DATE OF (B)(4) 2013 AND IT SHOULD HAVE BEEN (B)(4) 2013

    Description of Event or Problem · 1

    A SURGEON'S OFFICE REPORTED THAT A VNS PATIENT WAS SEEN ON (B)(6) 2013 AND IT WAS OBSERVED THAT THEIR GENERATOR INCISION SITE WAS OOZING AND OPEN. THE PATIENT WAS REFERRED FOR A BATTERY REPLACEMENT AND WOUND EXPLORATION, AND ANTIBIOTICS WERE PRESCRIBED. THE PATIENT HAS AN ONGOING ISSUE WITH NEEDING TO HAVE POCKET REVISION SURGERY. A CLINIC NOTE WAS RECEIVED DATED (B)(6) 2013. IN HER HISTORY IT REPORTS THAT THE PATIENT'S GENERATOR HAD MIGRATED INTO THEIR BREAST TISSUE THIS WAS REPOSITIONED. ADDRESSED IN MEDWATCH NUMBER: 1644487-2011-01242. CURRENTLY SHE IS EXPERIENCING IRRITATION AND POSSIBLE GRANULATION/INFLAMMATION LOWER IN THE CHEST AND IN THE BREAST WITH INDURATION. THEIR DEVICE WAS INTERROGATED AND SHOWED ROUGHLY 40-50% ON THE BATTERY. THE PATIENT HAD THEIR GENERATOR REPLACED ON (B)(6) 2013. IT HAS BEEN RETURNED FOR ANALYSIS BUT NOT COMPLETED AT THIS TIME. PREVIOUSLY THE PATIENT WENT TO SURGERY ON (B)(6) 2012 FOR LEFT CHEST WOUND EXPLORATION. THE PATIENT HAD A GRANULATING WOUND OF THE LEFT CHEST. THE PATIENT'S GRANULATION TISSUE WAS REMOVED AND IMMEDIATELY REVEALED THE WIRES THAT WERE IMMEDIATELY UNDER THE SKIN. ANOTHER POCKET WAS CREATED AND THE GENERATOR AND WIRES MOVED INTO IT. SHE DID WELL AND WAS DISCHARGED.

    Description of Event or Problem · 1

    THE GENERATOR WAS RETURNED DUE TO LOW BATTERY AND DEMIPULSE EOS STATUS UNKNOWN. RESULTS OF DIAGNOSTIC TESTING INDICATED THAT THE BATTERY STATUS INDICATED IFI=YES IN THE LAB. THE BATTERY IS PARTIALLY DEPLETED, 2.795 VOLTS, AT IFI, AS MEASURED DURING COMPLETION OF TEST PARAMETER 7.16.10.2 OF THE FINAL ELECTRICAL TEST. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 104.245% OF THE BATTERY HAD BEEN CONSUMED. 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

    THE PATIENT WAS SEEN FOR FOLLOWUP ON (B)(6) 2013. THEY CONTINUE TO HAVE MIGRATION AND DEHISCENCE ISSUES WITH THEIR NEW GENERATOR THAT WAS IMPLANTED (B)(6) 2013 ADDRESSED IN MEDWATCH REPORT NUMBER: 1644487-2013-01211

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98270 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 201721

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR