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

Model Number 302-20

Device Problems Corroded (1131); High impedance (1291); Mechanical Problem (1384)

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

Event Date 06/22/2016

Event Type  malfunction  

Event Description

It was reported by the nurse at the physician's office that the patient's device had high impedance.The device was programmed off and x-rays were ordered.The patient was then referred for surgery.It was later reported by the nurse that the high impedance was "just a fluke" and she "got it corrected so there actually was not a problem".The company representative spoke with the nurse who further explained she lowered the output current and re-ran the diagnostics and everything was fine.She then programmed the patient back to his normal settings and ran diagnostics two more times to verify that everything was fine.The nurse noted the patient was squirming a lot which may have caused the communication between the programming wand and the patient's generator to break.The nurse noted the diagnostic results seen when she noted the high impedance was under 10,000 ohms.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported by the physician's office that at the time the high impedance was originally observed, the patient was not referred for x-rays or referred for surgery.It was also noted that the patient was brought in on (b)(6) 2016, after the initial report of high impedance, and had the vns checked by the physician and no issues were observed.The patient had another follow up visit on (b)(6) 2016 where the high impedance was observed once again.The patient's generator was programmed off, he was referred for x-rays, and referred for a surgical consultation.It was noted the patient was disabled and can sometimes be unmanageable.The patient's mother stated she did not think there was any trauma that had occurred which could have caused the high impedance; however, she did state sometimes the patient has been known to slip through the enclosed bed.A/p and lateral x-ray images of the chest and neck were reviewed.It was noted that there were two fractures; one below where the anchor tether was believed to be located, and another below where the observed tie-downs were located.The internal programming history database was reviewed and showed high impedance was observed on (b)(6) 2016, (b)(6) 2016, and (b)(6) 2016 for system diagnostics.The programming history also confirmed the patient had been programmed off on (b)(6) 2016.No known surgical interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Describe event or problem; corrected data: this information was inadvertently left off of supplemental #02 mfr.Report.If explanted, give date; corrected data: this information was inadvertently left off of supplemental #02 mfr.Report.Date received by manufacturer; corrected data: this information was inadvertently incorrectly reported on the supplemental #02 mfr.Report.The date should have been (b)(6) 2016 on the supplemental #02 mfr.Report.If follow-up, what type; corrected data: "additional information" was inadvertently left off of supplemental #02 mfr.Report.

Event Description

It was reported the patient had a full revision of the generator and the lead on (b)(6) 2016.After the revision, diagnostic testing was performed and was within normal limits.The devices are expected to be returned, but have not been received by the manufacturer to date.

Manufacturer Narrative

Relevant tests/laboratory data: this information was inadvertently left off of the initial mfr.Report.Evaluation codes: this information was inadvertently left off of the initial mfr.Report.

Manufacturer Narrative

This information was inadvertently left off of the supplemental #05 mfr.Report.(b)(4).

Event Description

Product analysis (pa) for the returned lead was completed.The reported allegation of lead fractures was confirmed during the analysis.It should be noted that a portion of the lead assembly, including the positive white electrode, was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product.Multiple lead fractures were observed and scanning electron microscopy (sem) was performed at the fracture sites to attempt to determine the cause of the fractures.Some of the fractures were mechanically damaged with evidence of pitting which prevented the identification of the fracture type.One fracture showed evidence of a stress induced break (rotational forces).It is believed that stimulation was present for a certain period of time after the breaks occurred as evidenced by the presence of the metal pitting.Low magnification sem showed characteristics typical of a lead discontinuity, which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching, or material dissolution.With the exception of the observed discontinuities, the condition of the returned lead portions 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 portions were performed and no other discontinuities were identified.Based on the findings in the pa lab, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of lead fracture.Pa for the returned generator was completed.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed the generator performed according to functional specifications.The final electrical test showed an ifi = no condition.There were no performance or any other types of adverse conditions found with the generator.

Event Description

The explanted lead and generator were received by the manufacturer.Although product analysis is expected, it has not been completed to date.

• 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: 5804830
• MDR Text Key: 50732342
• Report Number: 1644487-2016-01625
• 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,Followup,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2012
• Device Model Number: 302-20
• Device Lot Number: 2266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2008
• 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: 17 YR