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

Model Number 102R

Event Date 09/01/2014

Event Type  Injury  

Event Description

Clinic notes were received for review which were dated (b)(4) 2014 and indicated that the patient was having painful stimulation from her vns. Normal mode diagnostics showed a dcdc of 4. The patient was also experiencing an increase in seizures frequency since the patient¿s last visit. The patient was observed in the clinic without any signs of pain or intolerance associated with her settings. The patient was noted to now be experiencing baseline seizure frequency. The physician indicated that since te patient is experiencing an increase in seizures and in (b)(6) 2014 reported isolated painful stimulation, this suggests her current battery is nearing end of service although the battery has not flagged ifi=yes. Therefore the patient was referred for surgery. Clinic notes dated (b)(4) 2014 were also received which indicated that the patient has been experiencing an increase in auras, not progressing into seizures at that time. The patient¿s normal mode diagnostics had increased to a dcdc of 4 and the patient was noted to be experiencing sporadic isolated painful stimulation. The physician indicated that due to the sporadic painful stimulation that started a couple of weeks prior and the diagnostics testing, she referred the patient for generator replacement. Clinic noted dated 06/06/2014 also indicate an increase in auras not progressing into seizures. Although surgery is likely, it has not occurred to date.

Event Description

It was reported that the patient underwent prophylactic generator replacement on (b)(6) 2015. The physician¿s assistant attributed the patient¿s increase in seizures to the device nearing end of service, per the battery life calculation on the generator. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the events. It was noted that the patient hasn¿t been seen by the physician¿s assistant since the generator replacement. The patient¿s generator was discarded after surgery by the hospital and therefore cannot be returned for product analysis.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 102R
• 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: 4401771
• Report Number: 1644487-2015-03576
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2014

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/09/2015
• 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: 102R
• Device LOT Number: 200929
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 10/15/2008
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 01/09/2015 Patient Sequence Number: 1