MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

Model Number 104

Event Date 01/24/2013

Event Type  Malfunction  

Event Description

Reporter indicated via clinic notes dated (b)(6) 2013 received to the manufacture that a patient was having recent increased seizures. The patient was admitted to the hospital after two weeks of pneumonia. Medication was increased as an intervention. Prophylactic replacement of the vns generator is possible. Attempts for additional information are in progress.

Event Description

Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. The physician reported that the increase in seizures were below the patient's pre-vns baseline frequency. It was reported that the patient was hospitalized in the icu due to respiratory problems at the time of the increase in seizures. The physician did not feel that vns played a role in the increased seizures. Attempts to have the device returned for analysis have been unsuccessful to date.

Event Description

The explanted generator was returned to the manufacturer. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 690 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows an ifi condition. The data in the diagaccum consumed memory locations revealed that 107. 632% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. However, a review of the internal memory locations within the generator suggests the existence of an error in calculating the device's total consumed energy. This error results in an incorrect device longevity estimate. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 104
• 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: 3109902
• Report Number: 1644487-2013-01356
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2013

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/13/2013
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 03/31/2009
• Device MODEL Number: 104
• Device LOT Number: 16869
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 11/14/2013
• Is The Reporter A Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/14/2013
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 04/09/2007
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial