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 01/24/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 it was reported that the patient underwent a full revision surgery that day due to high lead impedance (impedance of > 10,000ohms) and prophylactic generator replacement.The lead was found completely severed.It was stated that the high impedance was first noticed that day during surgery.No manipulation or trauma was believed to have caused or contribute to the impedance or severed lead.The explanted lead and generator were returned for product analysis.Product analysis on the generator was completed and no abnormal performance or any other type of adverse condition was found.Product analysis on the leads is still underway.

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 death or serious injury.

Event Description

Analysis of the returned lead portion was completed.During the visual analysis the positive connector ring quadfilar coil appeared to be broken approximately 20mm from the electrode bifurcation and the negative connector pin quadfilar coil appeared to be broken at approximately 22mm.Scanning electron microscopy was performed on the positive connector ring quadfilar coil break (found at 20mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage.Scanning electron microscopy was performed on the negative connector pin quadfilar coil break (found at 22mm) and identified the area on two of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, fine pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture on one of the broken coil strands.The areas on the remaining broken quadfilar coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type with fine pitting and residual material.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.With the exception of the observed discontinuities, the condition of the returned lead portion 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 portion were performed, during the visual analysis, and no other discontinuities were identified.Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.

• 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: 3639451
• MDR Text Key: 16797979
• Report Number: 1644487-2014-00493
• 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: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2006
• Device Model Number: 302-20
• Device Lot Number: 010850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2004
• 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: 37 YR