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

Model Number 102

Device Problem Low Battery (2584)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2014 note that the patient has experienced good control of seizures.It was noted that the battery life is low and generator replacement is recommended to continue control of seizures.The notes indicate that the patient is not having seizures, but that the patient is complaining of episodes of abnormal sensations on the left side of the face.The patient describes the sensations as his face and head being twisted.The notes indicate that the patient experienced these sensations prior to vns and that vns fully controlled these together with the seizures.The notes indicate that the patient is concerned the vns is not working.The device was interrogated and found to be working within normal limits and was not at end of service.It was noted that the patient would be referred for generator replacement.An implant card was received indicating that the generator was replaced on (b)(6) 2014 due to prophylactic reasons.The generator was returned for analysis.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Event Description

Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.The generator performed according to functional specifications.There were no anomalies found with the pulse generator.Additional information was received stating that the vns patient was not experiencing an increase in seizures.

• 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: 3668141
• MDR Text Key: 4200129
• Report Number: 1644487-2014-00643
• 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: 02/07/2014

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: 02/28/2006
• Device Model Number: 102
• Device Lot Number: 10388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 03/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2004
• 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: 60 YR