BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2961937 · Received February 14, 2013

    Report

    Report Number
    1644487-2013-00401
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 15, 2012
    Report Date
    January 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
    MX
    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

    PRODUCT ANALYSIS WAS COMPLETED AND APPROVED FOR THE EXPLANTED GENERATOR ON (B)(6) 2013. VISUAL EXAMINATION PERFORMED AT THE BENCH REVEALED SCRATCHES ON THE GENERATOR CAN. THESE SCRATCHES ARE MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE EXPLANT PROCEDURE, AS THE OBSERVED MARKINGS ARE CONSISTENT WITH DEVICES TYPICALLY USED IN A SURGICAL PROCEDURE (FORCEPS, ETC). NO OTHER SURFACE ABNORMALITIES (SUCH AS SHARP EDGES, HEADER DELAMINATION, OPEN POCKETS, DECOMPOSITION, CORROSION OR VOIDS) WERE NOTED ON THIS DEVICE. THE GENERATOR WAS RETURNED DUE TO EXTRUSION AND NO MALFUNCTION SUSPECTED/IDENTIFIED. RESULTS OF DIAGNOSTIC TESTING INDICATED THAT THE BATTERY STATUS INDICATED IFI=NO IN THE PA LAB. THE BATTERY VOLTAGE WAS 2.994 VOLTS, (NOT 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 3.844% OF THE BATTERY HAD BEEN CONSUMED. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATION. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. THE PHYSICIAN ASKED HOW THE CASE SHOULD PROCEED AS THE PATIENT HAD REJECTION AND INTOLERANCE OF THE IMPLANT, AND STATED THAT THEY WANTED TO IMPLANT THE PATIENT WITH VNS AGAIN IN THE FUTURE. HOWEVER, A DATE OF RE-IMPLANT WAS NOT PROVIDED. ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT'S LEAD WAS EXPLANTED DUE TO DIRECT EXPOSURE OF THE CABLE FROM A BRAKE ON THE SUTURE (REPORTED IN MANUFACTURER REPORT NUMBER: 1644487-2013-01144), WHICH IS RELATED TO THE PREVIOUSLY REPORTED EVENTS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO A PROBLEM WHICH WAS SUSPECTED TO HAVE OCCURRED FROM THE SUTURE. THE PATIENT WAS IMPLANTED ON (B)(6) 2012 AND HAD BEEN DOSED FOUR TIMES FROM THIS DATE TO AN OUTPUT CURRENT OF 1.25MA. PICTURES OF THE PATIENT SHOW THAT THE AREA OVER THE GENERATOR BODY AND THE ELECTRODE SITE APPEAR RED AND SWOLLEN WITH DRAINAGE AT THE GENERATOR SITE. THERE IS AN OBVIOUS OPENING OF THE WOUND OVER THE GENERATOR BODY WHERE THE GENERATOR AND A PORTION OF THE LEAD ARE VISIBLE. THE SUTURE AND LEAD CAN ALSO BE SEEN AT THE ELECTRODE SITE. RED SCARRING WAS OBSERVED WHERE THE SUTURES ONCE WERE. THE ISSUE WAS FIRST OBSERVED FOUR MONTHS FOLLOWING THE IMPLANT. THE PATIENT'S GENERATOR WAS REMOVED AS AN INTERVENTION; HOWEVER, THE LEAD WAS LEFT IN PLACE. THE PHYSICIAN SUSPECTS THAT THE CAUSE OF THE INJURY WAS RELATED TO THE SUTURE; HOWEVER, THE EXACT CAUSE IS UNKNOWN. NO TRAUMA OCCURRED WHICH MAY HAVE CONTRIBUTED TO THE EVENT. PER THE PHYSICIAN, THE PATIENT IS SUFFERING FROM SPONTANEOUS CRISIS, FLEXIONS AND EXTENSIONS (ABOUT 100 DAILY), AND ATONIC CRISIS (FOUR PER DAY) WITH INCREASE. THE PLAN IS TO PLACE THE GENERATOR ON THE RIGHT SIDE OF THE PATIENT ONCE THE PATIENT HAS HAD ADEQUATE RECOVERY FROM THE SCAR. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT AN INFECTION WAS DETECTED SHOWING GRANULATED TISSUE FOR TWO MONTHS, PARTICULARLY ON THE IMPLANTED AREA BY THE GENERATOR AND ELECTRODE SCAR. THE INFECTION WAS TREATED WITH ANTIBIOTICS BUT WITHOUT ANY RESULTS. THE PATIENT'S GENERATOR WAS REMOVED ON (B)(6) 2013. THE GENERATOR HAS NOT BEEN RETURNED AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAD BEEN RECEIVED THAT THE PATIENT WAS RE-IMPLANTED.

    Description of Event or Problem · 1

    CULTURES WERE TAKEN TO CHECK FOR INFECTION AND CAME BACK NEGATIVE, WHICH INDICATED THAT THERE WAS NO INFECTION AND ONLY A SECRETION. PER THE PHYSICIAN, THE GENERATOR WAS THEREFORE REMOVED BECAUSE THE SKIN WAS INFLAMMATORY. FOLLOW UP WITH THE PHYSICIAN FOUND THAT THE PATIENT'S ATONIC SEIZURES INCREASED AFTER THE VNS DEVICE WAS REMOVED BY 50 TO 60 PERCENT. IT WAS STATED THAT THIS INCREASE IN ATONIC SEIZURES AND SPASMS WAS DUE TO THE VNS REMOVAL. PRIOR TO VNS, THE PATIENT HAD ABOUT 100 OR MORE DAILY SPASMS, WHICH DECREASED WITH THE VNS IMPLANT. THE EXPLANTED GENERATOR WAS RETURNED ON (B)(6) 2013 AND IS PENDING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65244 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3361

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR