MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Therapeutic Response, Decreased (2271)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The patient reported that she has experienced a recent exacerbation of cardiac arrhythmia.The patient attributes this to vns and reported that she is on low settings.The patient indicated that she has a history of arrhythmia for which she is followed by a physician.The patient reported that experienced five straight days of severe arrhythmia, but that it is not as bad anymore.The patient reported that she was originally diagnosed with premature ventricular contraction two to three years ago.The patient indicated that she had a feeling vns therapy affected it.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Additional information was received stating that the vns patient was briefly hospitalized in mid-(b)(6) 2014 after experiencing a blackout.The treating physicians attributed the blackout to either bradycardia, cva or a clotting disorder.The patient¿s description of the event suggested that the event was not arrhythmia but an absence seizure.The patient was last seen by her neurologist on (b)(6) 2014 so the neurologist is unable to provide any feedback regarding the event.The patient has not been seen by a medical professional to date.

Manufacturer Narrative

Outcomes attributed to adverse event, corrected data: additional information indicates that the patient was hospitalized.

• Brand Name: PULSE GEN MODEL 105
• 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: 3688946
• MDR Text Key: 4292128
• Report Number: 1644487-2014-00725
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2014
• Device Model Number: 105
• Device Lot Number: 202019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2012
• 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): Hospitalization; Other
• Patient Age: 49 YR