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

Model Number 302-20

Device Problem Disconnection (1171)

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

Event Date 03/12/2015

Event Type  malfunction  

Event Description

The suspect lead was received by the manufacturer.Analysis of the device is underway but it has not been completed to date.

Event Description

It was reported that the vns patient had undergone a lead replacement due to lead discontinuity.It was reported that the impedance of the new lead was within normal ranges, dcdc code 1.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.The explanted device has not been returned to date.

Manufacturer Narrative

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

Event Description

Analysis of the returned portion of the lead was completed and found that the quadfilar coil 1 appeared to be broken approximately 26mm and quadfilar coil 2 appeared to be broken at approximately 30mm from the end of the cut outer-inner silicone tubes.Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting on two of the broken coil strands.Pitting was observed on the coil surface.Scanning electron microscopy was performed on the detached portion from quadfilar 1 coil break (found at 26mm) and identified the area on one end as having extensive pitting which prevented identification of the coil fracture type.The areas on two of the broken coil strands, on the opposite side were identified as being mechanically damaged which prevented identification of the coil fracture type with pitting.The areas on the remaining two broken coil strands were not visible due to the positioning on the fixture.Pitting was observed on the coil surface.Scanning electron microscopy was performed on the quadfilar coil 2 coil break and identified mechanical damaged which prevented identification of the coil fracture type, no pitting and flat spots on 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 puncture and slice marks and 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 found 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.What appeared to be white deposits were observed in various locations.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.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

• 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: 4705248
• MDR Text Key: 5839502
• Report Number: 1644487-2015-04466
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2015

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: 10/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 04/20/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/08/2015; 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2005
• 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: 39 YR