MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Failure to Deliver Energy (1211); Unexpected Therapeutic Results (1631)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099); Tingling (2171); Therapeutic Response, Decreased (2271)

Event Date 08/01/2014

Event Type  Injury  

Event Description

It was reported that the patient started having worse seizures two months ago that are more frequent and are now gtc¿s, which he didn¿t have for years.The vns didn¿t seem to abort the seizures anymore with a magnet swipe and the patient no longer feel stimulation.On the patient¿s visit on (b)(6) 2014 the vns was successfully interrogated and the settings were increased, however the patient still feels that it is not working.The patient was referred for surgery.Although surgery is likely, it has not occurred to date.Clinic notes were received which indicate that since the (b)(6) 2014, the vns does not seem to be reacting to magnet swipes.It was noted that before, the magnet would decrease the severity of the seizure and the patient had a subjective tingling in his throat.Now the patient doesn¿t have a tingling when the magnet is passed and the mother doesn¿t notice a change to his seizure severity.Additional information has been requested from the physician, but no further information has been received to date.

Event Description

It was reported that the physician has not seen this patient since (b)(6) 2013, although this was the physician who initially reported the events.The patient underwent prophylactic generator replacement on (b)(6) 2014.The explanted generator cannot be returned for product analysis as the hospital discards explants.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 103
• 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: 4248445
• MDR Text Key: 4986862
• Report Number: 1644487-2014-03018
• 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: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2012
• Device Model Number: 103
• Device Lot Number: 2779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2010
• 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): Other
• Patient Age: 23 YR