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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Seizures (2063); Therapeutic Effects, Unexpected (2099); Tingling (2171)

Event Date 07/08/2014

Event Type  Injury  

Event Description

Additional information was received via implant card that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to the painful stimulation.The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description

It was reported that the vns patient was having some breakthrough myoclonic seizures while previously being seizure free.The patient was also experiencing a tingling sensation but was unable to feel magnet mode stimulation when she swiped her magnet.The patient¿s device was tested and diagnostic results showed normal device function.The patient¿s device settings were increased, but the patient reportedly did not feel stimulation in the same way as before and began having pain in her left arm with stimulation.The neurologist decreased the patient¿s device settings and the patient was reported to be doing well.X-rays dated (b)(6) 2014 were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block; however, this could not be confirmed as the pin was not clearly shown to pass all the way through the connector block.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Based on the images provided, the cause of the reported events remains unknown.No known surgical interventions have occurred to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

Event Description

Additional information was received that the patient's painful stimulation and tingling began reoccurring in the neck and chest on (b)(6) 2015 despite no abnormal or strenuous activity by the patient.The vns device was interrogated and two diagnostic tests were performed which showed normal results.The generator was disabled.At first, the patient stated that she still felt stimulation, but after she was told that the device was off, then she said she couldn¿t feel it anymore.The patient's neurologist says that it could be psychosomatic symptoms.X-rays were taken but the radiologist stated there was no change from the previous x-rays in (b)(6).The device was thus temporarily disabled with magnet mode left enabled.Clinic notes were received from the appointment which confirmed the allegation that the patient was having pain in her left neck and left chest and that the device was disabled.It was also stated that these patient adverse events are similar to the pain event reported in mfr.Report # 1644487-2011-02585.Additional clinic notes stated that diagnostics were taken again and were within normal limits.The diagnostic tests reportedly caused significant discomfort immediately and resolved as the device turned off.The referring physician suspected that perhaps there is conduction of stimulation to surrounding tissues.No known surgical interventions have occurred to date.

• 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: 3970627
• MDR Text Key: 6021359
• Report Number: 1644487-2014-01905
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2013
• Device Model Number: 103
• Device Lot Number: 3077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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: 38 YR