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

Model Number 302-20

Device Problems Break (1069); High impedance (1291)

Patient Problem Fall (1848)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance (5969 ohms).It was reported that x-rays were taken and showed a clear lead break.The device was programmed off after observing the high impedance.The patient suffered a fall 10 days prior to the high impedance reading; however, it was reported that the fall was not significant.It was reported that the impedance has slowly increased over time.The patient has been referred for surgery.No known surgical intervention has been performed to date.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Further information was received indicating that the patient underwent revision surgery on (b)(6) 2015.The suspect lead was explanted and a replacement lead was implanted.The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits with 1352 ohms.Return of the explanted lead to the manufacturer is expected but it has not been received to date.

Event Description

The explanted lead was returned to the manufacturer on 08/20/2015 for analysis.Product analysis results confirmed discontinuity of both positive and negative quadfilar coils in the body region of the returned lead portions; also observed abraded openings of both the outer and inner tubing near the break location.During the visual analysis of the returned 316mm portion, the end of the (-) connector pin quadfilar coil appeared to be broken approximately 265mm and the end of the (+) connector ring quadfilar coil appeared to be broken at approximately 266mm from the end of the connector boot.Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 265mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type.Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 266mm) and identified the area on two of the broken coil strands as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type.The area on the third broken coil strand was identified as having extensive pitting which prevented identification of the coil fracture type.The area on the remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture and no pitting.Pitting was observed on the coil surface.During the visual analysis of the returned 84mm portion quadfilar coil 1 appeared to be broken approximately 2mm and quadfilar coil 2 appeared to be broken at approximately 4mm from the end of the abraded open / outer / inner silicone tubes.Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 2mm) 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 two remaining broken coil strands were identified as having evidence of a stress induced fracture (rotational forces) which most likely completed the fracture and no pitting.Scanning electron microscopy was performed on the quadfilar coil 2 coil break (found at 4mm) and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance), mechanical damage and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on two of these broken coil strands.The area on the fourth broken coil strand was identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and no pitting.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 openings and incision mark found on the outer silicone tubing, 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.The abraded openings found on the inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes.With the exception of the observed discontinuities and the abraded inner tubing, 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
• 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: 4528898
• MDR Text Key: 5545216
• Report Number: 1644487-2015-03905
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2013
• Device Model Number: 302-20
• Device Lot Number: 201189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2009
• 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: 18 YR