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

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 12/23/2013

Event Type  malfunction  

Event Description

Diagnostics performed during the patient's vns generator replacement surgery (due to end of service) found high impedance.Diagnostics could not be performed prior to the surgery, as the vns battery was depleted.After replacement with the new generator, diagnostics performed showed an impedance value of greater than 10,000 ohms.The lead pin was re-inserted into the generator multiple times; however, this did not resolve the high impedance.The lead was replaced and final diagnostics showed normal impedance at a value of 2,315 ohms.Attempts were made for additional information; however, they were unsuccessful.No other information was provided.

Event Description

It was reported that the generator and lead were ready to be returned for analysis.The devices were returned to manufacturer on 04/11/2014.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death.Adverse event and/or product problem, corrected data: the initial manufacturer report inadvertently did not include that the report was also an adverse event.Outcomes attributed to adverse event, corrected data: the initial manufacturer report inadvertently did not include the outcomes attributed to the adverse event.Relevant tests/laboratory data, corrected data: the initial manufacturer report inadvertently did not include information regarding the patient¿s increase in seizures and depression.

Event Description

It was previously reported that the vns patient was experiencing an increase in seizures and an increase in depression.The patient's device had reportedly been at end of service for some time.Analysis of the returned generator and lead was completed.The end of service condition was determined to be the result of normal battery depletion.The depletion was an expected event as determined by blc and battery voltage measurement.The module performed according to functional specifications.There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.During the visual analysis of the returned 240mm lead portion, quadfilar coil 1 appeared to be broken approximately 2mm from the end of the abraded open / cut / outer silicone tubing.Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting.The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting.Pitting was observed on the coil surface.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity.The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded opening observed on one of the inner silicone tubes.With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the high impedance.Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 3582656
• MDR Text Key: 4034278
• Report Number: 1644487-2014-00273
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2006
• Device Model Number: 302-20
• Device Lot Number: 010939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2004
• 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