MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 103

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Emotional Changes (1831); Seizures (2063); Cognitive Changes (2551)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported through clinic notes that the patient was experiencing behavioral dysfunction and learning difficulties.It was also noted that the patient had experienced a seizure however baseline seizure rate is unknown.The physician believed these symptoms may be related to the generator being at ifi=yes.The patient was then referred for generator replacement which occurred on (b)(6) 2016.To date the explanted generator has not be returned for product analysis.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

The generator was received and underwent product analysis.During analysis the generator was monitored for a 24 hour period and no variations in output current were noted during this testing period.Upon interrogation in the lab an end of service warning message present.Review of the internal data on the generator found that the battery had 2.049 volts which is an end of service condition.The pa lab found that the generator performed to all functional specifications, except for the end of service condition.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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: 5609073
• MDR Text Key: 43677531
• Report Number: 1644487-2016-00893
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2013
• Device Model Number: 103
• Device Lot Number: 201883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2011
• 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: 15 YR