MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Seizures (2063); Neck Pain (2433); Cognitive Changes (2551)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was initially reported the patient was having issues per the mother.It was reported that the patient was having changes in behavior correlating to seizure activity as well as heart rate changes that preceded seizures.The patient's device was seen to have lead issues and also the patient felt mild electric shock in the throat/neck which the patient described as a "tingle that hurts".Generator data was received and reviewed, and showed the device showed high impedance.The representative confirmed that high impedance was seen on the device.Surgery occurred and the surgeon first tried flushing out the generator and when the lead was re-inserted, high impedance was still observed.A test resistor was tried with the generator and impedance was normal thus a lead revision occurred.The representative noted that the patient's lead appeared to have fluid inside but that the lead got "mangled" while the surgeon was removing the lead.It was reported that the lead and generator were discarded and thus have not been received into analysis to date.No additional 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 11286373
• MDR Text Key: 234546659
• Report Number: 1644487-2021-00187
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2013
• Device Model Number: 302-20
• Device Lot Number: 201284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2009
• 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 Outcome(s): Required Intervention
• Patient Age: 15 YR