MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-30

Device Problems Corroded (1131); Fracture (1260)

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

Event Date 01/20/2017

Event Type  malfunction  

Event Description

Clinic notes mentioned that high impedance was observed on a patient's device.The patient's device was not programmed off during the clinic visit, per the patient's request.The patient was referred for revision surgery.No additional relevant information has been received to date.No surgical intervention has occurred to date.

Event Description

The patient underwent lead and generator replacement surgery due to the high impedance.The company representative present at the surgery indicated that the generator, which had been implanted 2 years prior, was the cause of the high impedance since the lead was initially replaced but did not resolve the high impedance.The explanted products have not been received by the manufacturer to date.No additional relevant information has been received to date.

Event Description

The explanted lead and generator were received by the manufacturer, but analysis has not been approved on the devices to date.No additional relevant information has been received to date.

Event Description

Analysis was approved for the generator.When received, the data was downloaded from the generator and reviewed.On (b)(6) 2017, a >25% increase in impedance was observed.The impedance value increased from normal impedance to high impedance.The next >25% change in impedance was observed on the date of explant from high impedance to normal impedance.The generator was interrogated, and system diagnostic tests were performed and returned results within the normal limits, indicating that there were no impedance issues with the generator.The generator performed according to functional specifications.Analysis was also approved for the lead.The lead was returned for analysis in two pieces.Three set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once.A lead break was identified in the positive coil, but the fracture mechanism could not be determined.Microscopy images of the positive coil show evidence of pitting at the lead break location.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• 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: 6732554
• MDR Text Key: 80691038
• Report Number: 1644487-2017-04185
• 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 Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2017

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: 01/31/2012
• Device Model Number: 303-30
• Device Lot Number: 2250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 08/24/2017; 09/26/2017; 10/24/2017
• Supplement Dates FDA Received: 09/18/2017; 10/20/2017; 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2009
• 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: 36 YR