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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); Weight Changes (2607)

Event Date 03/31/2014

Event Type  Injury  

Event Description

It was reported that the patient experienced a loss of appetite and weight loss.The device was programmed off as a result.It was reported that the events were probably related to device surgery and possibly related to device stimulation.The events were noted to be ongoing.It was noted that the device was disabled at the patient's request and that evaluation would be performed on whether the device would be programmed back on or if is dropped completely.No additional relevant information has been received to date.

Event Description

It was reported that the serial number of the generator is unknown and the serial number previously provided belonged to the lead, not the generator.

Event Description

Additional information was received stating that the vns study patient did not continue with the study as the loss of appetite and weight loss had not resolved.

Manufacturer Narrative

Corrected data: this date was inadvertently left off of follow-up mfr.Report #01.The date should have been reported as 07/10/2014.Follow-up mfr.Report #01 was not a late submission.

Manufacturer Narrative

Corrected data: new information received that the suspect device information is unknown.

Event Description

Further information was received indicating that the loss of weight had resolved.The event stopped on (b)(6) 2014.The patient recovered.

• Brand Name: PULSE GEN MODEL 102
• 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: 3886929
• MDR Text Key: 4541279
• Report Number: 1644487-2014-01556
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2014
• Device Model Number: 102
• Device Lot Number: 3492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2012
• 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 Age: 49 YR