MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem High impedance (1291)

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

Event Date 09/23/2019

Event Type  malfunction  

Event Description

An implant card was received that indicated the patient's generator was replaced prophylactically.The lead impedance with the replacement generator was indicated as high, >=10,000 ohms.Diagnostics prior to the generator replacement are unknown to date.The or support specialist company representative indicated that the surgeon does not historically let representatives in the operating room.A surgical resident indicated that there was high impedance, prior to the surgeon entering the room.The representative suggested troubleshooting, but it is unknown to date if the troubleshooting was performed as the representative was not able to go into the room.At the end of the generator replacement case it was reported that there was still high impedance detected, the resident indicated that they inspected the lead and "noticed kinking and a small cut in the lead tubing." no known relevant surgical intervention has occurred with the suspect product, the lead, to date.No further relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9191162
• MDR Text Key: 162653903
• Report Number: 1644487-2019-01999
• 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
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2003
• Device Model Number: 300-20
• Device Lot Number: 2702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2001
• 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: 46 YR