BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3142448 · Received June 3, 2013

    Report

    Report Number
    1644487-2013-01650
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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

    INFORMATION WAS RECEIVED ON (B)(4) 2013 THAT THIS PATIENT WOULD BE UNDERGOING VNS REVISION AND WOUND WASHOUT. IT WAS LATER STATED THAT THE EVENT WAS TECHNICALLY A SCAR REVISION. CLARIFICATION WAS RETURNED THAT WHEN THE PATIENT WAS TAKEN IN FOR SCAR REVISION, IT WAS DISCOVERED THAT THE GENERATOR WAS SURROUNDED BY A POCKET OF PUSS. THE DEVICE WAS EXPLANTED. THE PATIENT WAS DOING WELL ON VNS. THE PATIENT¿S MOTHER STATED THAT SHE WENT FROM HAVING 7 SEIZURES A DAY TO LESS THAN ONE A MONTH. CULTURES WERE TAKEN BUT THE RESULTS WERE NOT PROVIDED. EXPLANT SURGERY TOOK PLACED ON (B)(6) 2013. THE EXPLANTED GENERATOR HAS NOT BEEN RETURNED. IT IS UNKNOWN IF THE LEAD WAS ALSO EXPLANTED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED VIA PHONE CALL ON (B)(6) 2013, TO THE MANUFACTURE THAT THE GENERATOR INCISION SITE FOR THE VNS PATIENT HAD BECOME RED AND RAISED. FOLLOW-UP WITH THE PHYSICIAN INDICATED THAT THIS WAS A POSSIBLE INFECTION DUE TO SURGERY AND THAT THE PATIENT WAS PLACED ON IV ANTIBIOTICS PER THE SURGEON AND WATCHED. THIS WAS DONE TO PRECLUDE A FULL INFECTION AND EXPLANTATION OF THE DEVICE AND THUS FAR THE INFECTION IS UNDER CONTROL. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE INFECTION. THE MOST RECENT SYSTEM DIAGNOSTIC RESULTS INDICATED THAT ALL WAS OK AND THAT THERE WAS NO HIGH LEAD IMPEDANCE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTER STATING THAT CULTURES WERE NOT TAKEN FROM THE PATIENT TO CONFIRM THE INFECTION.

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE PATIENT'S LEAD WAS EXPLANTED ALONG WITH THE GENERATOR. THE EXPLANTED DEVICES WERE RETURNED AND PRODUCT ANALYSIS WAS PERFORMED. A SECTION OF THE LEAD ASSEMBLY WAS RETURNED FOR ANALYSIS IN ONE PIECE AS SHOWN. THE LEAD¿S ELECTRODES WERE NOT RETURNED FOR EVALUATION. SETSCREW MARKS WERE SEEN ON THE CONNECTOR PIN, PROVIDING EVIDENCE THAT PROPER CONTACT BETWEEN THE SETSCREW AND THE LEAD PIN EXISTED AT LEAST ONCE. ALSO, THE CONNECTOR RING HAS SCRATCHES MOST LIKELY CAUSED BY THE CANTED SPRING IN THE PULSE GENERATOR HEADER DURING INSERTION OF THE LEAD CONNECTOR. THE EXACT POINT IN TIME OF WHEN THIS OCCURRED IS UNKNOWN. ABRASIONS WERE IDENTIFIED ON THE CONNECTOR BOOT. ABRASIONS WERE IDENTIFIED ON THE OUTER SILICONE TUBING AT APPROXIMATELY 2-5.7CM AND 6.1-6.6CM FROM BOOT. THE ENDS OF THE LEAD COILS ARE CUT/TORN AT APPROXIMATELY 6.5CM FROM BOOT. THE OUTER TUBING END IS CUT AT APPROXIMATELY 6.6CM FROM BOOT. INCISIONS IN THE SILICONE TUBING WERE NECESSARY TO PERFORM PROPER INSPECTION OF THE LEAD COILS. USING A MULTIMETER (03140C) RESISTANCE MEASUREMENTS OF THE LEAD WERE PERFORMED AFTER ITS DECONTAMINATION: FROM RING CONNECTOR (+) TO END OF COIL: 37.9 OHMS FROM CONNECTOR PIN (-) TO END OF COIL: 37.2 OHMS NO DISCONTINUITIES WERE IDENTIFIED WITHIN THE RETURNED LEAD PORTION. THE RETURNED PORTION OF THE LEAD (CONNECTOR INCLUDED) MEASURED APPROXIMATELY 10.9CM IN LENGTH. NOTE THAT SINCE A SIGNIFICANT PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. THE GENERATOR WAS RETURNED DUE TO THE ALLEGATION OF INFECTION AND SCARRING. THE DATA IN THE DIAGACCUM CONSUMED MEMORY LOCATIONS REVEALED THAT 4.418% OF THE BATTERY HAD BEEN CONSUMED. VISUAL EXAMINATION SHOWED TOOL MARKS ON THE PULSE GENERATOR CASE MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE EXPLANT PROCEDURE. SIGNS OF DISCOLORATION WERE ALSO OBSERVED ON THE PULSE GENERATOR CASE CONSISTENT WITH THE ADHERED REMNANTS OF DRIED BODY FLUIDS FOLLOWING AN EXPLANT PROCESS. THE SEPTUM WAS NOT CORED. NO OTHER SURFACE ABNORMALITIES WERE NOTED ON THIS DEVICE. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244133 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202321

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention