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

Model Number	302-20
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Fall (1848); Therapeutic Response, Decreased (2271)
Date of Event	04/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event or Problem Description
It was reported that the patient's vns system registered high lead impedance.The patient was reported to have had a fall a few weeks prior, but it was not definitively stated to be the cause of the suspected lead issue.Follow up confirmed the high impedance was observed on a system diagnostics.Clinic notes were later received that contained details on how the high impedance was discovered.Due to the age of his generator, the group home staff was swiping the magnet once a month to ensure that it was still functioning.The last time the magnet was used, the patient was unable to feel stimulation.On interrogation of his vns at the physician's office, the high lead impedance was discovered.No surgical interventions have occurred to date.No additional pertinent information has been received to date.
Event or Problem Description
The patient's full revision surgery was completed on 05/27/2016.The impedance on the replacement system was within normal limits.The explanted lead and generator were received by the manufacturer on 06/13/2016.Product analysis was completed on the returned generator on 06/22/2016.Other than typical explant procedure related observations, visual analysis noted no surface abnormalities on this device.The device performed according to functional specifications.Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.Product analysis for the suspect lead is underway.
Event or Problem Description
Product analysis for the returned lead portions was completed on 07/01/2016.Although returned in four separate pieces, the entire device was returned for analysis.A lead fracture was confirmed on one of the returned segments.During the visual analysis, a returned portion of the lead coil appeared to be broken approximately 28mm from the electrode bifurcation.Scanning electron microscopy was performed on the coil break and identified the area as having evidence of a stress induced fracture with mechanical damage and pitting.The area on the remaining broken coil strand was identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and pitting.Sem performed on the mating end of the break identified an area on one of the broken coil strands as having extensive pitting which prevented identification of the coil fracture type.The area on the remaining broken coil strands was identified having evidence of a stress induced fracture with mechanical damage and pitting.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Continuity checks of the returned lead portions were performed and no other discontinuities were identified.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 anomalies were noted.
Additional Manufacturer Narrative
Date received by manufacturer, corrected data: follow-up report #1 inadvertently listed the incorrect date.The correct date is (b)(6) 2016.

• Brand Name: LEAD MODEL 302
• Common Device Name: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 5687676
• Report Number: 1644487-2016-01161
• Device Sequence Number: 16701645
• Product Code: LYJ
• Combination Product (Y/N): N
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2016

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2006
• Device Model Number: 302-20
• Device Lot Number: 010182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Event Location: Other
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/05/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 05/30/2016
• Supplement Report FDA Received Date: 06/24/2016; 07/20/2016; 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR