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 03/21/2014

Event Type  malfunction  

Event Description

It was reported that the patient had generator and lead replacement surgery on (b)(6) 2014.The explanted devices were returned for analysis.Analysis was completed on the generator.The device performed according to functional specifications.Analysis concluded that no abnormal performance or any other type of adverse condition was found with the generator.Analysis of the lead has not been completed to date.

Event Description

Attempts for additional information have been unsuccessful.

Event Description

It was reported that device diagnostics resulted in high impedance.It is unknown if any patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance.It was later reported that x-rays were performed and would be sent to manufacturer for review.It is unknown if the device was programmed off per manufacturer's recommendations.No surgical intervention has been performed to date.Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative

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

Event Description

X-rays were received and reviewed by manufacturer.Based on the x-rays received, the cause for the reported events are unable to be determined.There was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out.As the lead could not be assessed, continuity in that portion of the lead cannot be confirmed.Due it image quality the lead that were difficult to visualize and fully assess.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.Review of x-rays by the manufacturer, no gross lead discontinuities visualized.

Manufacturer Narrative

Manufacturing device history records were reviewed.Review of the lead device history records confirmed all quality specifications were passed prior to distribution.Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description

An analysis was performed on the returned lead portions.During the visual analysis of the returned 200mm portion quadfilar coil 1 appeared to be broken approximately 174mm from the end of the cut outer / inner silicone tubes.Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 174mm) and identified the area on one 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 second broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting.The two remaining broken coil strands were identified as being pitted with mechanical damaged which prevented identification of the coil fracture type.Pitting was observed on the coil surface.Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 174mm) and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting.The remaining broken coil strands were 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 which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.The abraded openings found on the outer and inner silicone tubes 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 and 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.

• 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: 3757980
• MDR Text Key: 5104149
• Report Number: 1644487-2014-01052
• Device Sequence Number: 1
• Product Code: MUZ
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2009
• Device Model Number: 302-20
• Device Lot Number: 200228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2006
• 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: 66 YR