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

Model Number 103

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

Patient Problems Undesired Nerve Stimulation (1980); Paralysis (1997)

Event Date 11/01/2017

Event Type  Injury  

Event Description

It was reported that the patient believed that she was experiencing erratic stimulation from the vns.It was stated that the patient believed the vns battery was possibly going dead.The patient was referred for prophylactic vns generator replacement.No relevant surgical intervention is known to have occurred to date.No additional relevant information has been received to date.

Manufacturer Narrative

Outcomes attributed to adverse event, corrected data: initial report inadvertently did not select 'required intervention to prevent permanent impairment/damage.'.

Event Description

Follow up with the patient's neurologist revealed that the patient had paralyzed vocal cords on the left side and the vns was disabled, including magnet mode, as a result.The physician stated that she found it strange that the patient developed vocal cord paralysis so long after the vns implantation and queried whether it was a result of a large seizure the patient did not recall.The patient was referred to an ent for further examination.The physician stated that she would like to further analyze the situation with the patient's vocal cord prior to replacing the vns or programming it back on.The physician felt that the vocal cord paralysis may be something unrelated to the vns, but wanted to determine this prior to proceeding further.X-rays were reviewed by the physician and no lead breaks were observed.Diagnostics were reported as fine with no impedance issues.It was reported that the patient underwent full vns explantation surgery.The explanted vns generator and lead have not been received by the manufacturer to date.

Event Description

During attempts at product return, it was revealed that the facility, historically, does not return explanted products and would need written consent from the patient.

Event Description

The facility reported that they would be returning the explanted products.It was stated that the explantation of the vns was at the patient's request.The explanted vns generator and lead were received by the manufacturer and are pending product analysis.

Event Description

Lead product analysis was completed.The allegations of vocal cord paralysis and erratic stimulation are beyond the scope of activities performed in the product analysis, or pa, lab.A majority of the lead assembly including the electrodes was not returned for analysis and, therefore, a complete evaluation could not be performed.All continuity testing of the returned lead portion passed with no discontinuities identified.No obvious anomalies were noted.The condition of the returned lead portion was consistent with those typically following explant.Generator product analysis was completed.Proper functionality in the generator to provide the programmed output currents was successfully verified in the product analysis, or pa, lab.The generator was placed in a simulated body temperature environment and monitored for more than 24 hours.No signs of variation in the output signal were observed and diagnostics were as expected.The battery measured 2.849 v at the completion of the fet, indicating an intensified follow-up indicator, or ifi, = no condition.The generator performed according to functional specifications.There were no performance or other adverse conditions found with the generator.

• 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: 7105104
• MDR Text Key: 94420044
• Report Number: 1644487-2017-04972
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2013
• Device Model Number: 103
• Device Lot Number: 201866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2011
• 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: 48 YR