MAUDE Adverse Event Report: CYBERONICS BIPOL LEAD MODEL 300

Device Problem High impedance (1291)

Patient Problem Fall (1848)

Event Date 09/08/2016

Event Type  malfunction  

Event Description

It was reported that vns patient who recently underwent a generator replacement surgery now has high lead impedance.It was reported that the patient was admitted to the hospital 3 weeks before the report for a procedure with another medical team.When the nurse attended interrogated the patient's device.A dcdc value of 7 was found and the output status was reported to be at "limit".All tests from generator replacement until this procedure were normal, with dcdc values of 0 or 1.It was reported that the patient had a number of falls, with one more significant fall during which he struck the right side of his chest/neck, rather than the left side.X-rays were taken and were reported by the physician to be unremarkable.The copy of xrays sent to manufacturer for review indicated that the placement of the generator looks normal from the images.The filter feed-through wires appeared to be intact.The lead connector pin appeared to be fully inserted.The lead wires at the connector pin cannot be assessed due to poor quality of the images.Strain relief bend and loop cannot be assessed from the images.Portions of the lead appeared to be behind the generator and could not be fully assessed.No acute angles or clear lead break were found in the parts of the lead that could be assessed.It was reported that the generator is currently turned on and appears to be functioning.Attempts for additional relevant information have been unsuccessful to date.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 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: 6043210
• MDR Text Key: 57929720
• Report Number: 1644487-2016-02412
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/28/2016

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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