MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-30

Device Problems Fluid/Blood Leak (1250); High impedance (1291)

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

Event Date 11/09/2017

Event Type  malfunction  

Event Description

It was reported that during replacement surgery, high impedance was seen after the generator was replaced.Pre-surgery the impedance was fine at around 1400 ohms.After the generator was replaced the impedance was over 9000 ohms.They had tried multiple troubleshooting steps, including numerous attempts at re-inserting the pin but it didn¿t resolve.They also inserted the test resistor and it still gave a reading over 9000.It was stated that the surgeon had another person hold the screwdriver in the set screw in order to relieve back pressure, while they tried to insert the pin.From the operating room representative (or rep), it appeared to be inserted fully, but it still read high impedance.It was also reported that the surgeon saw fluid within the patient¿s lead, near the lead pin.It is not clear whether interrogations were only performed or if diagnostics were actually performed during surgery.Follow-up showed that the or rep tried rebooting the programmer and then re-inserting the test pin into the generator.The impedance after this was 4000 ohms.She then stated when they re-attached the generator to the electrode the impedance was 4000 ohms.The device was interrogated again and the final impedance was 1851 ohms.A review of the design history record for the lead was performed and showed no non-conformances were prior to distribution.No additional or relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7087462
• MDR Text Key: 94412647
• Report Number: 1644487-2017-04941
• 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
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/15/2010
• Device Model Number: 302-30
• Device Lot Number: 200551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2007
• 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: 22 YR