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 07/08/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested during an office visit on 07/08/2014 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms).No trauma is suspected to have caused or contributed to the reported high impedance; however, it was noted that the patient is in a wheelchair with straps going across his chest and that he is frequently picked up from his wheelchair.The patient underwent generator and lead replacement surgery on (b)(6) 2014.The explanted generator and lead have not been returned 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 a death or serious injury.

Event Description

The lead and generator were received for analysis.The implant card confirmed that the lead and generator were explanted due to lead discontinuity and the lead impedance with the new system was within normal limits.Analysis of the generator was completed on 09/03/2014.Electrical test results showed that the pulse generator performed according to functional specifications.There were no adverse functional, mechanical, or visual issues identified with the returned generator.Analysis of the lead was completed on 09/04/2014.During the visual analysis of the returned 329mm portion the (+) white electrode quadfilar coil appeared to be broken approximately 23mm and 24mm from the electrode bifurcation.Scanning electron microscopy was performed on the (+) white electrode quadfilar coil break (found at 23mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting.Pitting was observed on the coil surface.Scanning electron microscopy was performed on the (+) white electrode quadfilar coil break (found at 24mm) 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.During the visual analysis of the returned 329mm portion the (-) green electrode quadfilar coil appeared to be broken approximately 23mm and 25mm from the electrode bifurcation.Scanning electron microscopy was performed on the (-) green electrode quadfilar coil break (found at 23mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage.Pitting was observed on the coil surface.Scanning electron microscopy was performed on the (-) green electrode quadfilar coil break (found at 25mm) and identified the area 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 which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.The abraded opening 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 found inside the outer silicone tubing.With the exception of the observed discontinuities 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.

• 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: 3968390
• MDR Text Key: 17992263
• Report Number: 1644487-2014-01895
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2013
• Device Model Number: 302-20
• Device Lot Number: 2491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2009
• 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: 8 YR