BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 303

    MDR report key: 3864292 · Received June 10, 2014

    Report

    Report Number
    1644487-2014-01461
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    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

    ON (B)(6) 2014 PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. RESULTS OF DIAGNOSTIC TESTING INDICATED THAT THE BATTERY STATUS INDICATED IFI=NO IN THE PA LAB. THE BATTERY VOLTAGE WAS 2.995 VOLTS (NOT AT IFI), AS MEASURED DURING COMPLETION OF THE FINAL ELECTRICAL TEST. 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. PRODUCT ANALYSIS ON THE LEAD WAS COMPLETED ON (B)(6) 2014. OTHER THAN THE TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT HAD AN OPEN WOUND AT HIS NECK INCISION SITE. GRANULATION TISSUE WAS OBSERVED EIGHT MONTHS AFTER IMPLANT AND THE OPEN WOUND WAS FIRST OBSERVED ON (B)(6) 2014. THE SURGEON STATED THAT THERE WAS NO OBVIOUS REASON FOR THE GRANULATION TISSUE. DEBRIDEMENT OF THE GRANULATION TISSUE WAS PERFORMED. THE SURGEON STATED THAT TRAUMA POSSIBLY HAD CAUSED OR CONTRIBUTED TO THE EVENT AS THE PATIENT HAD SEIZURES AND HIT THE AFFECTED AREAS. NO CAUSAL OR CONTRIBUTOR MEDICATION CHANGES PRECEDED THE ONSET OF THE EVENT. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT WAS GIVEN ANTIBIOTICS AND THE PATIENT¿S ISSUES RESOLVED. THE PATIENT¿S ISSUES CAME BACK AND THE SURGEON STATED THAT THE DEVICE NEEDED TO BE EXPLANTED DUE TO ABSCESSES AT THE LEAD SITE. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT DEVELOPED ANOTHER PUSTULE AT HIS NECK INCISION SITE. THE SURGEON PREVIOUSLY PACKED THE WOUND AND THE GRANULATION TISSUE APPEARED TO RESOLVE BY (B)(6) 2014. HOWEVER, GRANULATION TISSUE WAS NOTED AT THE SAME SITE DURING AN OFFICE VISIT ON (B)(6) 2014. THE SURGEON SPECULATED THAT AN INFECTION HAD DEVELOPED OR THE PATIENT¿S BODY WAS REJECTING THE DEVICE. CULTURES SHOWED MODERATE STAPH. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2014 TO EXPLANT HIS GENERATOR AND LEAD. THE EXPLANTED GENERATOR AND LEAD HAVE BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340467 LEAD MODEL 303 LEAD LYJ CYBERONICS, INC. 303-20 202391

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention