MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Information (3190)

Event Date 08/21/2015

Event Type  Injury  

Event Description

It was reported on (b)(6) 2015 from a vns depression patient's husband that he is looking for a physician to adjust the vns.It was mentioned that the patient is currently in the hospital but no information regarding the reason for the hospitalization or relationship to vns was provided.Attempts have been made for more information but no relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5078881
• MDR Text Key: 25854390
• Report Number: 1644487-2015-05795
• Device Sequence Number: 1
• Product Code: MUZ
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/04/2008
• Device Model Number: 102
• Device Lot Number: 016030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2006
• 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: 60 YR