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

Model Number 302-20

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

Patient Problem No Code Available (3191)

Event Date 12/07/2015

Event Type  malfunction  

Event Description

It was reported that high impedance was found during pre-operative vns generator checks.It was noted the generator was replace prophylactically and lead pin re-insertions were attempted during surgery; however, lead impedance continued to go up.Therefore, the lead was replaced and the high impedance resolved.The surgeon noticed an obvious lead break with lead dissolution upon explant.The explanted lead was received by the manufacturer for analysis.Product analysis is expected but has not been completed to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Product analysis for the explanted lead was completed.It was noted that a portion of the lead assembly, including the electrodes, was not returned.Both stress induced fractures (fatigue fractures and rotational fractures) along with mechanical damage were found.Pitting was observed on the coil surface suggesting that stimulation was present for a certain period of time.Low magnification scanning electron microscopy analysis of the quadfilar coil shows characteristics typical of a lead discontinuity.Abraded openings were also found on the lead.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 except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one point in time.Additional setscrew marks found on the 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 visual analysis, and no other discontinuities were identified.Based on the findings in the product analysis lab, there is evidence to suggest discontinuity in the returned portions of the device, which may have contributed to the stated allegations.

Manufacturer Narrative

Describe event or problem; corrected data: the information contained in this section was inadvertently left out of the supplemental #01 mfr.Report.

Event Description

Product analysis also determined that abraded openings in the inner and outer portions of the lead, along with the cut ends of the lead made during the explant process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing in the tubing 1 section of the lead.In the second section of the lead that was returned, tubing 2, there was no obvious path for fluid ingress other than the cut ends that were made during the explant procedure.

• 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: 5335664
• MDR Text Key: 35218423
• Report Number: 1644487-2015-06870
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2015

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: 02/28/2009
• Device Model Number: 302-20
• Device Lot Number: 200111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/01/2016; 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2006
• 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: 31 YR