MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Seizures (2063); Toxicity (2333)

Event Date 09/27/2014

Event Type  Death  

Event Description

Clinic notes dated (b)(6) 2014 reported that the patient's seizures were of stable condition; however, interrogation of vns showed that ifi=yes (intensified-follow-up indicator).The patient was referred for generator replacement surgery.Additional information later received reported that the patient was scheduled for generator replacement on (b)(6) 2014 but the patient was in the hospital and seizures were too unstable to go for surgery.Follow-up with the patient¿s treating vns physician was performed.It was reported that the patient¿s increased seizures occurred approximately around (b)(6) 2014.The patient¿s device was interrogated on (b)(6) 2014 and was reported to be ¿1/3 full.¿ on (b)(6) 2014, there were approximately three seizures per day recorded.The increased seizure frequency began around (b)(6) 2014 when it was reported to be around 50 seizures per day.There were no likely external factors that may have contributed for the increased seizures.The patient was admitted to the hospital on (b)(6) 2014 for presumed medicinal toxicity.During hospitalization, the seizure frequency increased to around 50 seizures per day.The patient¿s caregivers elected supportive care only, with do-not-resuscitate status with no further escalating care.The patient passed away on (b)(6) 2014.Good faith attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description

The funeral home did not have a record available of the device being explanted.

• Brand Name: PULSE GEN MODEL 103
• 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: 4203871
• MDR Text Key: 14874605
• Report Number: 1644487-2014-02841
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2011
• Device Model Number: 103
• Device Lot Number: 2617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2010
• 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): Death; Required Intervention
• Patient Age: 12 YR