MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Material Erosion (1214); Material Protrusion/Extrusion (2979)

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

Event Date 12/01/2012

Event Type  Injury  

Event Description

Analysis of the returned generator and lead was completed.There were no adverse functional, mechanical, or visual issues identified with the returned generator.Electrical test results showed that the pulse generator performed according to functional specifications.The abraded open / cut and slice marks found on the outer silicone tubing of the returned lead portion.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 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 and the slice marks observed on the (+) unmarked inner silicone tubing.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted except for the setscrew marks found near the end of the (+) marked and (-) unmarked connector pins indicating the lead had not been fully inserted into the cavity of the generator.The additional setscrew marks found on the lead connector pins 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, with no discontinuities identified.Based on the findings, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints.Note that since a portion of the (-) unmarked connector inner silicone tubing and quadfilar coil, a portion of the (+) marked inner silicone tubing and outer silicone tubing including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description

It was reported that the patient¿s lead was breaking through the skin on the patient¿s neck in (b)(6) 2012.On (b)(6) 2013, the patient underwent surgery to reposition the patient¿s lead.During the procedure, the neurosurgeon noted that there was excessive lead coiled in the patient¿s neck around the vagus nerve believed to be due to erosion.The patient was seen by his physician on (b)(6) 2014 and it was reported that the lead erosion had not been resolved.The patient was referred for surgery.No known interventions have occurred to date.Attempts for additional relevant information were made but have been unsuccessful to date.

Event Description

It was reported that the patient underwent generator and lead explant due to infection.The patient was admitted for intervention of the eroding lead, but also showed signs of granulation at the generator site.It was reported that after excavating the lead, there was pus found around the generator with infection in the surrounding tissue.It was decided to abandon the planned replacement and resolve the infection.The explanted generator and lead were received for analysis.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 3753014
• MDR Text Key: 4532689
• Report Number: 1644487-2014-01008
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 300-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 35 YR