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

Model Number 102

Device Problem Device Issue (2379)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 11/11/2014

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2014 note that the patient was experiencing an increase in seizure activity.The patient¿s last seizure was (b)(6) 2014.The device was interrogated and found to be at end of service.The patient was referred for generator replacement.The physician reported that the vns being at end of service is believed to have contributed to the increase in seizures.It is unknown whether or not the increase in seizures is above the patient's pre-vns baseline frequency.No known surgical interventions have been performed to date.

Event Description

It was discovered that the wrong patient had been identified in the previous mfr.Report.The patient identify is corrected in this report.It was discovered that the patient had undergone generator replacement on (b)(6) 2014 due to battery depletion.The lead impedance with the new generator and existing lead was within normal limits.The explanted generator has not been received for analysis to date.

Manufacturer Narrative

Manufacturer Narrative

The wrong patient was reported previously.

• Brand Name: PULSE GEN MODEL 102
• 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: 4338614
• MDR Text Key: 5139864
• Report Number: 1644487-2014-03381
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2010
• Device Model Number: 102
• Device Lot Number: 2196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2008
• 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: 26 YR