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

Model Number 103

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2017

Event Type  malfunction  

Event Description

It was reported that a patient's device was at ifi = yes during a clinic visit.The patient had only been implanted for 3 years and was not at high settings, so the physician's assistant was concerned that the ifi flag appeared prematurely.The patient was referred for replacement surgery.It was later reported that the patient had an upper endoscopy performed 7 months after implant.The type of tools used during the endoscopy are unknown.A programming history review revealed no anomalies in the available programming history.No additional information has been provided to date.No surgical intervention has taken place to date.

Event Description

Programming history was reviewed with the data from the date of implant through 1.5 years after implant.There was no indication that the battery was depleting quicker than normal, and there was no evidence that the device had come into contact with an electrocautery tool after implant surgery.It was reported that the patient had generator replacement surgery.The reason for replacement was indicated as premature battery depletion/ifi yes.The explanted generator was not interrogated nor were diagnostic tests performed prior to surgery.A second decoder was performed using data from 1.5 years after implant through the date of the event.A comparison of the charge consumed and the corresponding voltage showed that the generator voltage was dropping quicker than normal.The generator was received, but analysis has not been approved to date.No additional information has been provided to date.

Event Description

Analysis was approved for the generator.When received, the data was downloaded from the generator and reviewed.Burn marks were observed on the pulse generator can and header, which indicated that the pulse generator may have been exposed to an electrocautery tool; however, it could not be determined if these marks were implant or explant related.Programming history did not indicate a low battery at the time of the implant.No other surface abnormalities were noted on this device.The generator was opened.A visual assessment of the internal circuitry revealed no visual anomalies.The generator was subjected to radiographic examination.No visual anomalies of the circuitry were noted during examination.A system diagnostic test performed yielded results within the normal limits and showed the device was at ifi = yes.The generator performed according to functional specifications.The ifi battery status showed that the battery was partially depleted, as measured during electrical testing.The battery voltage was measured, and results showed that the measurement circuit was operating properly.The manufacturing device history was reviewed.No anomalies were noted during review and all steps met specification.The cause of the premature battery depletion could not be determined; however, the battery depletion appears to possibly be premature based on the downloaded data.The battery has been sent to the vendor for further analysis, but no further information regarding the analysis has been received to date.The patient was noted to have undergone a generator repositioning surgery 1 year after implant; however, it is unknown if electrocautery was used during the surgery.The patient's implanting physician did not have any programming data available from the date of implant as the surgeon does not have a programming system.No additional relevant information has been provided.

Event Description

Additional analysis of the generator battery was performed externally by the battery manufacturer, and the results of testing were returned.The open circuit voltage, mid-cell thickness, impedance and microcalorimetry measurements of the battery component are all consistent with a beginning to middle of life cell.The cathode separator was thoroughly inspected at two different magnifications.No defects were noted in the cell assembly.The internal glass-to-metal seal was also thoroughly inspected.The cell exhibited an acceptable pin to lid resistance value.Additionally, the header assembly passed leak testing.No defects were identified during the destructive analysis that would account for the early depletion of the cell as noted by the vns manufacturer.No additional relevant information has been provided to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 6356300
• MDR Text Key: 68288239
• Report Number: 1644487-2017-03254
• 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,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2015
• Device Model Number: 103
• Device Lot Number: 3747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2013
• 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: 32 YR