MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735)

Event Date 03/01/2013

Event Type  Injury  

Event Description

It was reported that the patient has an infection and will undergo generator explant.It was reported that the lead will be left in place.It was reported that reimplant is planned at a later time.It was reported that the patient has a chronic neck infection that appears to be associated with the vns.Several types of antibiotics were tried ; however, the neck incision reopened again.It was noted that a small amount of granulation tissue is in the medial aspect of the neck wound.The patient underwent generator explant on (b)(6) 2014.It was reported that the explanted device will not be returned for analysis.The physician reported that the infection started six months following implant.The patient became sick and was hospitalized.The physician reported that the infection started at the generator site and traveled to the neck through the tunneled site.It was reported that the neck wound grew (b)(6).Multiple antibiotics were administered and the neck site was ok.The physician reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the infection.No additional relevant information has been received to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS INC; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS INC; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 3815763
• MDR Text Key: 19797928
• Report Number: 1644487-2014-01274
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2014
• Device Model Number: 103
• Device Lot Number: 202105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR