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

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291); Low Battery (2584); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Emotional Changes (1831); Depression (2361); No Code Available (3191)

Event Date 10/04/2016

Event Type  malfunction  

Event Description

It was reported that the patient underwent generator replacement surgery due to an end of service generator.Prior to surgery the generator could not be communicated with due to battery depletion.During surgery the generator was replaced and high impedance was observed with the existing lead and the new generator.Pin insertion troubleshooting was then attempted.The surgeon reinserted the existing lead's pin into the new generator multiple times however the high impedance did not resolve.He then performed a generator diagnostic test on the new generator and a test resistor which showed that the generator was functioning properly.The existing lead was then reinserted into the new generator and high impedance was once again observed.The surgeon then decided to replace the lead at a later surgery.The generator was then programmed on because the surgeon felt that even if the patient was not receiving therapy due to the high impedance she would at least benefit from a placebo effect from knowing the device was on.It was reported that x-rays were taken pre-operatively and the physician did not observe a lead issue however these x-rays have not been received by the manufacturer.The psychiatrist was then informed of the manufacturer's recommendations to program the device off if high impedance is seen.However it is unknown if the psychiatrist did program the device off.Later the patient reported that she needed the lead replaced because she was very depressed and made suicidal statements.No surgical interventions are known to have occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient underwent surgery to address the high impedance.During the surgery the surgeon attempted to re-insert the lead pin into the generator to determine if inadequate pin insertion was the cause of the high impedance.However the high impedance did not resolve and the surgeon proceeded with a lead replacement.A diagnostic test at the end of the surgery confirmed that the existing generator and new lead were functioning properly.The explanted lead has not been received to date.

• 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: 6060435
• MDR Text Key: 58713096
• Report Number: 1644487-2016-02487
• Device Sequence Number: 1
• Product Code: MUZ
• 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,Followup
• Report Date: 01/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2006
• 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 Outcome(s): Other
• Patient Age: 52 YR