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

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Fever (1858); Unspecified Infection (1930)

Event Date 07/21/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was seen in the emergency room the past friday night.The patient was started on antibiotics and did not have any fever.The patient was scheduled to see the surgeon.The patient had recently undergone generator replacement.The patient was seen by the surgeon who drained "milky fluid" from the wound at the chest pocket.The area was flushed and cultures were taken.The surgeon administered iv antibiotics.The surgeon believes an infection is present and was considering explant.It was later reported that the patient was experiencing wound dehiscence.The patient's family feels the device needs to be removed.The patient was admitted to the hospital and underwent generator explant.It was reported that the lead was left in place.Attempts to obtain additional information have been unsuccessful to date.

Event Description

The physician reported that the cultures were positive for staphylococcus aureus.It was reported that the generator and a portion of the lead were explanted.The physician reported that the infection was a result of implant surgery and the presence of the device.There wa no patient manipulation or trauma that is believed to have caused or contributed to the infection.The device protrusion was secondary to the wound infection and wound dehiscence.The patient is now stable and did not experience systemic symptoms and the local infection has resolved.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4018076
• MDR Text Key: 19539294
• Report Number: 1644487-2014-02043
• 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,Followup
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Model Number: 103
• Device Lot Number: 3836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 7 YR