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

Model Number 302-20

Device Problems High impedance (1291); Malposition of Device (2616)

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

Event Date 12/24/2013

Event Type  malfunction  

Event Description

It was reported that the explanted generator and lead were not discarded and would be returned for analysis.The generator and lead were received for analysis.Analysis is underway, but has not been completed to date.

Event Description

It was reported that the patient's parents have decided to explant the device.A high quality x-ray image was sent to manufacturer which identified a lead break in a portion of the lead.The patient underwent generator explant.It was reported that the lead electrode was left implanted.It was reported that the generator was discarded by the operating room nurse.

Manufacturer Narrative

Report source, corrected data: supplemental manufacturer report #02 inadvertently did not include the report source.Date received by manufacturer, corrected data: supplemental manufacturer report #02 inadvertently did not include (b)(4) 2014 as the date received by the manufacturer.

Event Description

It was reported that device diagnostics resulted in high impedance (>10,000 ohms).The reported that he would see the patient again to program the device off and x-rays would be taken.It was reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance.X-rays were reviewed by manufacturer.A sharp angle was identified in the lead which could contribute to the high impedance.It was also noted that the lead pin did not appear to be fully inserted into the generator header which could also be a cause for the high impedance.The physician reported that he wants to leave the generator programmed off for approximately 3-6 months to see if the patient's condition worsens.The physician does not believe that the patient had any real benefit from vns therapy.It was reported that if the patient's condition worsens then the patient will be referred for lead replacement surgery.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.Device manufacturing records were reviewed.X-rays reviewed by the manufacturer identified a sharp angle in the lead.The lead pin did not appear to be fully inserted in the generator header.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies.Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.Date of event, corrected data: additional information indicates that the event occurred at least on (b)(6) 2013.

Event Description

Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.During analysis of the returned lead portion, the slice mark 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.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted except for the set of setscrew marks found at the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator.The additional 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 and no discontinuities were identified.Based on the findings, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to the reported high impedance.Note that since a large portion of the lead assembly was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2013.

• 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: 3672504
• MDR Text Key: 4501784
• Report Number: 1644487-2014-00656
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 02/11/2014

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: 10/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 03/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/18/2014; 05/22/2014; 05/28/2014; 06/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2008
• 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: 15 YR