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 06/10/2016

Event Type  malfunction  

Event Description

During patient's generator replacement surgery, diagnostics were run and they indicated high impedance with impedance of 7129 ohms on the newly implanted generator and existing lead.The surgeon then pulled out pin and reinserted just to check if it were a lead pin issue.The impedance was still high at 8870 ohms.The surgeon then used test resistor pin to make sure it was not a generator issue.The generator diagnostics came back within normal limits with the test resistor.Therefore, the high impedance was determined to be a lead issue and the lead was revised.Diagnostics after the lead revision were within normal limits with impedance of 985 ohms.The explanted devices were received on (b)(6) 2016.Analysis is underway but has not been completed to date.

Event Description

An analysis was performed on the returned lead portions and the reported allegation of fracture of lead(s) was confirmed.During the visual analysis of the returned lead, multiple electrode quadfilar coils appeared to be broken.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 and no pitting.Scanning electron microscopy was performed on another portion of the electrode quadfilar coil and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting on one of the broken coil strands.Flat spots were 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 which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.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 set screw marks found on the lead connector pins 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 , there is evidence to suggest a discontinuity in the returned portions of the device.The reported allegations of "failure to program due to eos" on the generator was duplicated in the pa lab.The electrical performance of the generator, as measured in the pa lab, was used to conclude that no anomalies exist and the end-of-service (eos) condition is an expected event.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: 5771771
• MDR Text Key: 49649605
• Report Number: 1644487-2016-01517
• 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: Occupational Therapist
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2011
• Device Model Number: 302-20
• Device Lot Number: 200822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2008
• 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