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

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 05/12/2016

Event Type  malfunction  

Event Description

A provider called to report that a vns patient's system was exhibiting high lead impedance.The provider indicated that the generator was last replaced in 2013 and at the last device check in (b)(6) 2016 the lead impedance was within normal limits at that time.A review of available programming and diagnostic history revealed no anomalies through (b)(6) 2015.No causal factors that might have contributed to the high lead impedance were known.The provider elected to disable the device output and refer the patient for revision surgery.Attempts for additional relevant information have been unsuccessful to date.No known surgical interventions have occurred to date.

Event Description

X-rays were taken after the high impedance condition was observed but no obvious anomalies were identified by the providers.The patient underwent full system revision on (b)(6) 2016.Pre-operative diagnostics indicated ok communication, low output current, high lead impedance, >=10,000 ohms, ifi - no.No abnormalities were seen in the main body of the lead however the surgeon identified an area near the bifurcation that appears to be kinked/fractured.The lead was cut at that point and a new lead was implanted with the electrodes being placed below the original electrodes.The generator was replaced prophylactically.The newly implanted system was tested and all measurements were within normal limits.The explanted products were explanted per hospital policy.

• 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: 5697782
• MDR Text Key: 47752618
• Report Number: 1644487-2016-01227
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2006
• Device Model Number: 302-20
• Device Lot Number: 010904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2014
• 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: 14 YR