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

Model Number 102

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Atrial Fibrillation (1729); Bradycardia (1751)

Event Date 05/04/2015

Event Type  Injury  

Event Description

It was reported on (b)(6) 2015 that the patient is experiencing very severe bradycardia with no evidence of asystole.This was diagnosed on (b)(6) although it may have started earlier.The patient is showing signs of atrial fibrillation followed by bradycardia as low as 20bpm.The device was deactivated with a pacemaker magnet and the patient showed no bradycardia after the magnet deactivation.The patient's device was then disabled to 0ma.

Event Description

The patient's following physician is aware of the situation and that the device was turned off by the icu.The patient has not seen the patient since the event and is unwilling to provide any additional information.Therefore, attempts for additional information have been made but no relevant information has been received to date.

Manufacturer Narrative

Review of the available programming and diagnostic history.

• 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: 4802826
• MDR Text Key: 5898387
• Report Number: 1644487-2015-04798
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

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: 11/30/2009
• Device Model Number: 102
• Device Lot Number: 1970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2007
• 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: 52 YR