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

Model Number 103

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Swelling (2091)

Event Date 05/08/2015

Event Type  Injury  

Event Description

It was reported that the vns patient woke up on (b)(6) 2015 with pain in the neck and redness around the generator site.Infection was suspected so the patient was given antibiotics.The patient's generator site was observed to be swollen and tender to touch, but the patient did not have a fever.Follow-up revealed that the surgeon did not suspect an infection but stated due to the patient's flexed posture, arm position and spasticity, the patient developed a hematoma that liquefied and caused the generator to pull away from the original implant site.Patient was given antibiotics as a precaution.Additional information was received stating that patient had developed an infection and was referred for surgery.The surgeon attributed the infection the generator migration and planned to re-implant the device deeper underneath the pectoral muscle.An implant card was received indicating that the vns patient underwent generator replacement surgery on (b)(6) 2015.

Manufacturer Narrative

Event Description

The explanted vns generator was received by the manufacturer for analysis.However, analysis has not been completed to date.No additional relevant information has been received to date.

• 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: 4907118
• MDR Text Key: 6832448
• Report Number: 1644487-2015-05163
• 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: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Model Number: 103
• Device Lot Number: 202602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 07/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2013
• 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: 21 YR