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

Model Number 105

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

It was reported that a vns patient was admitted to the icu with a fall.It was reported that the patient keeps going into status.It was reported that the patient's device would be checked.No additional information was provided to date.

Event Description

Additional information from the nurse indicated that it was felt the status was due to sepsis from his recent injury and nothing to do with vns.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.Later, it was confirmed by the nurse that the status was not due to vns, but sepsis related.It was reported that the vns patient has a history of previous status.The nurse reported that the patient's device was interrogated during a follow-up visit; its settings were: 1.75ma output current - 30hz frequency - 250usec pulse width - 30sec on time - 3min off time - 2ma magnet output - 500usec mag pulse width - 60sec magnet on time.The device was tested and system diagnostics returned impedance results within normal limits with 2671 ohms.

• Brand Name: PULSE GEN MODEL 105
• 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: 5966409
• MDR Text Key: 55258638
• Report Number: 1644487-2016-02134
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Model Number: 105
• Device Lot Number: 3938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• 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
• Patient Age: 28 YR