MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fatigue (1849); Pain (1994); Seizures (2063); Twitching (2172)

Event Date 08/12/2015

Event Type  malfunction  

Event Description

It was reported that the patient does not feel that the vns is working.The patient cannot feel stimulation when she swipes the magnet.The patient feels that the device has been acting "funny" for several weeks.The patient had two seizures on (b)(6) 2015, which was reportedly an increase in seizures so the patient went to the er.While at the er, it was reported that the patient's vns was not working at all.The er was unable to locate the vns generator with the wand and an x-ray had to be done to locate it.Additional information as received that the patient feels her vns stimulating erratically, and it is somewhat painful.The patient can still not feel magnet swipes.2 magnets have been used without success.The patient also is complaining of tiredness and seems "twitchy." no additional relevant information has been obtained to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 5055377
• MDR Text Key: 25638431
• Report Number: 1644487-2015-05700
• 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: company representative,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/10/2015
• Device Model Number: 103
• Device Lot Number: 202592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: 32 YR