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

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 01/17/2017

Event Type  Injury  

Event Description

It was reported that the patient's output current turned to zero due to an unknown reason.The patient had previously been programmed to 1.5 ma.Because of the loss in therapy, the patient experienced an increase in seizures.The patient was programmed back on.As the patient's generator is a model 102, it is susceptible to programming anomalies that may occur during programming or diagnostics as addressed in the device's labeling.Therefore this can reasonably be attributed to a programming anomaly.Per labeling, the patient's device should be interrogated at the end of each appointment in order to prevent the patient from leaving with unintended settings caused by a programming anomaly.No further relevant information has been received to date.

Event Description

It was reported that when the patient's generator was found to be programmed off, the patient's seizure rate was the same as baseline.After the generator was reprogrammed on, the patient's seizure rate improved, but the rate was not as good as before the vns was unintentionally disabled.Review of the programming history found that a programming anomaly occurred on (b)(6) 2017 that left the patient's device unintentionally disabled.The physician did not perform a final interrogation and the disabled output current wasn't corrected until (b)(6) 2017.No further relevant information was received to date.

Event Description

It was determined that the programming anomaly event described in supplemental mdr 1 was the anomaly that caused the patient's increased in seizures.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 6641856
• MDR Text Key: 77601484
• Report Number: 1644487-2017-03979
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2017
• Device Model Number: 102
• Device Lot Number: 203494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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): Other
• Patient Age: 4 YR