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

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Seizures (2063); Therapeutic Response, Decreased (2271); Choking (2464)

Event Date 04/10/2014

Event Type  malfunction  

Event Description

X-rays were received and reviewed.Review of x-rays identified that the negative lead electrode may not be fully attached to the patient's nerve as the orientation of the electrode appears more parallel to the nerve rather than wrapped around it.No other obvious discontinuities were identified with the vns system.The patient was referred for vns replacement surgery.No known surgical intervention has been performed to date.

Event Description

It was reported that the vns patient was having difficulty breathing and had a slight choking sensation.The neurologist lowered the patient¿s device settings.The patient subsequently had an increase in petit mal seizures so the neurologist decreased the device off time which helped with the patient¿s seizures.The patient continued to have difficulty breathing.Further follow-up revealed that the patient continued to have an increase in seizures.X-rays were provided to the manufacturer where analysis is currently underway.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(4) 2010.

Event Description

On (b)(6) 2014 it was reported that the patient¿s lead impedance was around 4,000ohms.The patient all of a sudden started having shortness of breath with stimulation; he couldn¿t breathe in or out.After two days, he went the physician and the vns was turned down three times.The patient was referred for surgery.Although surgery is likely, it has not occurred to date.

Event Description

It was reported on an implant card received on (b)(6) 2014 that the reason the lead was replaced was because of a ¿lead discontinuity¿.The lead impedance after the full revision was 1852 ohms, within normal limits.

Event Description

On (b)(6) 2014 it was reported that the patient underwent a full revision surgery.It was reported that the explanted products cannot be returned to the manufacturer for product analysis as the hospital does not return explanted products.

Event Description

On (b)(6) 2014 it was reported that they were not certain about a lead break, the physician just insisted that a full revision be done because the patient was complaining of pain at the lead site.X-rays had been obtained but the source of the pain and relatively high impedance could not be located.The physician suspected that there was a lead break; however it could not be confirmed.The therapeutic consultant noted that it did look like the lead casing had been breached as there was blood and debris within the silicone casing of the lead, which is why the physician suspected lead discontinuity.It was noted that it appears like the patient¿s symptoms have resolved since this revision.

Manufacturer Narrative

Corrected data: the initial mfr.Report inadvertently reported that x-rays had not been received; however, the x-rays had been received for review.

Manufacturer Narrative

Review of the available programming and diagnostic history.

Manufacturer Narrative

Corrected data: inadvertently did not include information on follow-up report #3.

• 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: 3884994
• MDR Text Key: 4599379
• Report Number: 1644487-2014-01546
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2011
• Device Model Number: 103
• Device Lot Number: 2604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2010
• 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 Age: 37 YR