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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problem Bradycardia (1751)

Event Date 07/10/2014

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital with bradycardia in the 40s bpm.The physician wants to rule out the vns as a trigger.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description

Additional information was received stating that the vns patient¿s bradycardia was not believed to be related to vns.The patient had viral gastroenteritis that led to emesis and issues sleeping, resulting in bradycardia.The patient did not have any prior history or family history of cardiac events nor any pre-existing medical conditions.Prior to the bradycardia, the patient¿s heart rate and blood pressure were approximately 60 bpm and 130/70 mm hg, respectively.During the event, they decreased to 130 bpm and 120/70 mm hg.The event did not occur along with diagnostic tests or with any changes to device settings or medications.No interventions were taken.The patient was hospitalized for monitoring.It was noted that the patient had vocal cord paralysis since being implanted on (b)(6) 2004 and that he was unable to tolerate an output current greater than 0.5ma.

• Brand Name: PULSE GEN MODEL 102
• 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: 4051930
• MDR Text Key: 4905615
• Report Number: 1644487-2014-02157
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2005
• Device Model Number: 102
• Device Lot Number: 10489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 09/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2004
• 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: 65 YR