MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Fluid/Blood Leak (1250); High impedance (1291)

Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2016

Event Type  malfunction  

Event Description

It was reported that the patient had a lead replacement surgery for high impedance.Additional information from a company representative was received.A lead fracture was not visualized during the surgery and incomplete pin insertion was ruled out as the cause of the high impedance.Attempts to retrieve the lead have been made, but the lead has not been received to date.Additional relevant information has not been received to date.

Event Description

The physician stated the date the high impedance was first discovered through interrogation of the device on (b)(4) 2016.The physician stated that falls due to seizures could have possibly contributed to the high impedance.The physician stated the impedance was ok when the current generator was placed.The physician did an assessment on patient x-rays.The assessment indicated a new configuration of the device in the upper left chest since prior radiographs.Ap lateral, repeat lateral, and oblique view of the vagus nerve stimulator device was performed showing nothing definitive for a lead disruption.There was a questionable gap upper limb vagus nerve stimulator lead on the oblique view, but when viewed in multiple other projections, no lead disruption can be confirmed, particularly the lateral view.The leads that extend downward in the chest to the generator appear intact.There appears to be a portion of the lead behind the generator that could not be assessed.The chest radiograph is normal otherwise.No definite lead disruption was indicated to have been seen when considering findings on four radiographs the explanted generator was received on 11/21/2016.Analysis is underway, but hasn't been completed to date.No additional relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: the generator replacement and return is reported in mfr.Report # 1644487-2016-02567.Previous supplemental mdr #1 inadvertently did not add this information.Previous supplemental mdr #1 inadvertently stated that the lead was returned, however the generator was returned, not the lead.The generator return is captured in mfr.Report # 1644487-2016-02567.Previous supplemental mdr #1 inadvertently stated that the lead was returned to the mfr, however the generator was returned, not the lead.The generator return is captured in mfr.Report # 1644487-2016-02567.Previous supplemental mdr #1 inadvertently stated that the lead was returned to the mfr and was awaiting analysis, however the generator was returned, not the lead.The generator return is captured in mfr.Report # 1644487-2016-02567.

Event Description

A return product form was received for the lead.The lead was not returned, however in the form it listed the reason for the lead return as "leads had fluid in them".Additional information from a nurse practitioner with the physician's operative notes was received.She stated that the surgeon did see fluid in the old lead from the lead replacement.Information from a livanova therapeutic consultant indicated that the reason for the fluid leak was that during the explant procedure, the surgeon cut the lead.He stated this was a normal part of the procedure and the cut was not pre-existing.He said this was the reason for the earlier report from the nurse practitioner.While the company representative believed that the fluid in the lead came from the surgeon cutting the lead as part of the explant process, this could not be confirmed to be the only source of fluid entering the lead.A device history review was performed and no unresolved non conformances were found.Analysis was performed on the returned generator.Review of the data downloaded shows an indication of increased impedance.On the implant date, the impedance was within normal limits at 2275 ohms.In (b)(6) 2016, the impedance was noted to be high at 11,405 ohms.On the date of explant, the impedance was noted twice; once at 4000 ohms, and another time at 17,985 ohms.The 4000 ohms was likely from a test with a test resistor, which indicates the generator was functioning properly.The 17,985 ohms was likely after the lead pin was re-inserted, which provides evidence that the lead is the cause of the high impedance.During analysis, interrogations and system diagnostics were performed and the device performed according to specification during testing with multiple resistances.The lead has not been received to date.The generator replacement, return, and analysis is captured in mfr.Report # 1644487-2016-02567 no additional relevant information has been received to date.

Event Description

Additional information indicates the hospital does not know what happened to the lead as they could not find it.It is possible that the lead was returned but it has not been received to date.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 6080191
• MDR Text Key: 59509237
• Report Number: 1644487-2016-02568
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2009
• Device Model Number: 302-20
• Device Lot Number: 200371
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2006
• 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: 18 YR