MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Pain (1994); Seizures (2063); Swelling (2091)

Event Date 02/15/2017

Event Type  malfunction  

Event Description

It was reported by the physician's office that the patient's generator had migrated and the edge was pushing against the skin causing a breakdown of tissue.Clinic notes were received showing the patient was referred for an urgent evaluation of an extruding generator.It was also noted the patient had been experiencing some discomfort at the generator site and that the generator had seemed to migrate towards the axilla and recently developed a bluish discoloration with thinning of the skin, but without discharge.The patient denied fever, chills, or any change in status and the generator was still functional.Subcutaneous fluid collection and swelling were also noted at the generator site.The patient was referred for explant of the generator and the lead.It was later reported by the physician that the patient did not have an infection as the culture had come back as negative.

Manufacturer Narrative

Describe event or problem; corrected data: this information was inadvertently left off of the initial mfr.Report.If explanted, give date; corrected data: this information was inadvertently left off of the initial mfr.Report.

Event Description

The patient underwent vns explant on (b)(6) 2017.The physician did not know the cause of the migration.

Event Description

It was reported that the patient was experiencing an increase in seizures that began prior to the explantation of the vns.No additional information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 6398375
• MDR Text Key: 69733343
• Report Number: 1644487-2017-03363
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2014
• Device Model Number: 102
• Device Lot Number: 3492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 64 YR