MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302-20

Model Number 302-20

Device Problem Degraded (1153)

Patient Problem No Code Available (3191)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

Patient underwent generator and lead explant due to voice alteration and coughing associated with vns stimulation.The surgery was reported to be for patient comfort and was not to preclude a serious injury.During the surgery on (b)(6) 2016, the surgeon noted a lead discontinuity.The explanted devices have not been received to date.

Event Description

The explanted devices was received on 06/02/2016.The generator performed according to functional specifications.Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.An analysis was performed on the returned lead portions and the reported allegations of; 'fracture of lead(s)' (lead section) was not confirmed.A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.The 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 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.With the exception of the observed abraded opening the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The set screw 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 portions were performed, during the visual analysis, and no other discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegation of 'fracture of lead(s)'.

• Brand Name: LEAD MODEL 302-20
• 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: 5700121
• MDR Text Key: 47892873
• Report Number: 1644487-2016-01243
• 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
• Report Date: 05/09/2016

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: 02/29/2012
• Device Model Number: 302-20
• Device Lot Number: 2284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 06/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2009
• 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: 27 YR