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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 06/01/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that the patient has been seizure free for the entire last year, however the last month he had four seizures.The nurse practitioner noted that she is concerned that the generator may be nearing end of life.The nurse practitioner later reported that the patient has been having breakthrough seizures and that she is concerned the generator is nearing end of service.She indicated that they will monitor the patient and if he continues to have seizures then they will replace the vns generator.No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase in seizures.The nurse practitioner stated that the patient only has one type of seizure and that the patient has had three breakthrough seizures.

Event Description

Clinic notes were received regarding the patient's replacement.In the clinic notes it was mentioned that the patient had 4 seizures in (b)(6) 2015, which were the only seizures the patient had that year.The patient was referred for prophylactic generator replacement due to the battery life calculation provided to the physician.No surgical intervention has occurred to date.

Event Description

The patient had prophylactic generator replacement surgery on (b)(6) 2016.The explanting facility does not return product to the manufacturer.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: 4959682
• MDR Text Key: 23337572
• Report Number: 1644487-2015-05405
• 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: Health Professional
• Type of Report: Followup,Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2013
• Device Model Number: 102
• Device Lot Number: 201883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/01/2016; 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2011
• 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 Age: 49 YR