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

Model Number 102

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Dyspnea (1816); Undesired Nerve Stimulation (1980); Pain (1994); Electric Shock (2554)

Event Date 05/02/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was shocking the patient on (b)(6) 2014.The patient¿s device was tested on (b)(4) 2014 and diagnostic results revealed high lead impedance.The patient¿s device was subsequently programmed off.No patient trauma had occurred.Clinic notes were received for the patient¿s office visit on (b)(6) 2014.The patient was last seen on (b)(6) 2014 and there was no evidence of a device malfunction at that time; the patient's device settings were reported to be stable.The notes indicate that the patient¿s device was providing stimulation on an irregular basis and was dysfunctional but did not cause any seizures.The shocking from the device caused coughing and pain.The patient went to the emergency room on 05/02/2014.The magnet was taped over the patient¿s device.The patient felt one pulse of stimulation and the device reportedly stopped responding.The patient did not have any seizures while in the er but did have 2-3 auras.During the office visit, the physician noted a little lateral gaze nystagmus and the patient¿s device showed high impedance.With the magnet removed, the patient jumped whenever his device delivered stimulation which caused coughing and pain.The magnet was taped back over the device and the patient¿s medication was increased.X-rays were provided to the manufacturer for review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The complete lead connector pin insertion could not be assessed due to the poor quality of the images provided.The electrodes appeared to be placed in normal arrangement.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 high lead impedance remains unknown.Incomplete lead pin insertion could be a possible cause of the high impedance.However, no definitive conclusions can be made with the images provided.Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014.The explanted generator has not been returned to date.Review of the available programming and diagnostic history showed normal diagnostic results through 12/28/2010.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.Review of the available programming and diagnostic history.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

Event Description

An implant card was received indicating that diagnostic results with the replacement generator and existing lead showed lead impedance within normal limits (impedance value ¿ 2644 ohms).

Event Description

Further information was received that the physician recalled that the patient also had continuous stimulation during the time the vns had high impedance.No further relevant information has been received to date.

• 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: 3838963
• MDR Text Key: 4620734
• Report Number: 1644487-2014-01379
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2010
• Device Model Number: 102
• Device Lot Number: 201269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2009
• 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: 54 YR