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

Model Number 302-20

Device Problems High impedance (1291); Failure to Interrogate (1332); Communication or Transmission Problem (2896)

Patient Problems Scar Tissue (2060); Seizures, Grand-Mal (2168)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

On 5/16/2016 the patient¿s mother reported that her daughter¿s generator was unable to be interrogated by the new physician and that her previous physician noted an ¿impedance issue¿ at the last appointment on (b)(6) 2015.The mother noted that it was very difficult to get her daughter's device managed because she was never able to consistently see a physician or at the same facility.The patient¿s mother then stated that over the last several months ((b)(6) 2015), her daughter has been having an increase in grand mal seizures and the mother was concerned that it would get worse.The mother confirmed that the patient is not as bad as she used to be prior to the vns therapy.The patient¿s mother later reported that high impedance had been seen during the clinic visit on (b)(6) 2015.At that time, no therapy level adjustment was made to discontinue therapy.The doctors had told the patient the high impedance was possibly due to scar tissue but therapy was allowed to continue.The patient¿s new doctor is unable to communicate with the patient's vns therapy system and the patient reports an increase in seizures as well as a failure of the magnet to abort the seizures.The patient¿s settings were noted to be output=2ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=1.1min.A review of the patient¿s programming history revealed that system diagnostics performed on (b)(6) 2015 showed results within normal limits and no high impedance.

Event Description

Generator and lead replacement surgery occurred on (b)(6) 2016.The explanted devices have not been received by the manufacturer to-date.

Manufacturer Narrative

Relevant test data, corrected data: the date of systems diagnostics was inadvertently reported as (b)(6) 2015, when the date was intended to be reported as (b)(6) 2013.

Event Description

Additional information was received that the patient was referred for revision surgery.It was reported that the device had been turned off for a while.The generator and lead were explanted on (b)(6) 2016.The explanted devices have not been received by the manufacturer to-date.Additional relevant information has not been received to-date.

Event Description

The explanted lead and generator were received.Analysis was completed for the returned lead portions.The lead coil appeared to be broken approximately 1mm and 2mm from the end of the electrode bifurcation.A short section of coil was observed between the two coil breaks.Scanning electron microscopy was performed on the coil break found at 1mm and identified the area as having extensive pitting which prevented identification of the coil fracture type.Pitting and flat spots were observed on the coil surface.Scanning electron microscopy was performed on the short section of the coil break found between 1mm and 2mm and identified the area as having extensive pitting which prevented identification of the coil fracture type.Scanning electron microscopy was performed on the coil break found at 2mm and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type.Pitting and flat spots were observed on the coil surface.Abraded openings were found on the outer silicone tubing, and most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.What appeared to be white deposits were observed on the connector boot.During the visual analysis electrode ribbons appeared to be partially embedded in what appeared to be remnants of dried body tissue.With the exception of the observed discontinuities, abraded openings and tissue covered electrode ribbons the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present.No other anomalies were noted.Analysis was completed for the returned generator.Review of the downloaded data from the pulse generator shows high impedance on the date of explant, (b)(6) 2016.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.The pulse generator was interrogated at multiple orientations adjacent to the programming wand.The pulse generator interrogated at all orientations.The device output signal was monitored while the pulse generator was placed in a simulated body temperature environment.Results showed that the device provided the expected level of output current for the entire monitoring period.Magnet activations performed during output monitoring, demonstrate the appropriate magnet output for the programmed settings.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, voltage measured 2.938 volts and shows the intensified follow-up indicator was not set.The downloaded data revealed that 26.496% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 5707811
• MDR Text Key: 48046259
• Report Number: 1644487-2016-01287
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/12/2016; 09/06/2016; 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2006
• 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: 19 YR