MAUDE Adverse Event Report: CYBERONICS PULST GEN MODEL UNK; GENERATOR

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported by the mother of a prospective patient that she had heard from a mother of a different patient that the child was implanted with vns and experienced an increase in seizures.The patient had the vns explanted, and once the vns was removed, the seizures improved.No additional information was received.

• Brand Name: PULST GEN MODEL UNK
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 6066734
• MDR Text Key: 58741897
• Report Number: 1644487-2016-02521
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 10/31/2016
• 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