MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-30

Device Problems High impedance (1291); Physical Property Issue (3008)

Patient Problems Fall (1848); Laceration(s) (1946); Seizures (2063)

Event Date 10/31/2016

Event Type  malfunction  

Event Description

It was reported the patient was seen by her physician and high impedance was observed on the vns.The patient was referred for full revision.The vns was programmed off.It was noted the patient had a seizure in (b)(6) 2016 and fell off her toilet and smashed her head on the floor resulting in a laceration.Since that point, the patient had felt a tightening in her throat when the device stimulated.The patient underwent full revision surgery on (b)(6) 2016.The surgeon noted that he identified an area in the lead which was damaged and replaced the lead.The generator was noted to be a prophylactic replacement.

• 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: 6117676
• MDR Text Key: 60904448
• Report Number: 1644487-2016-02692
• 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: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2010
• Device Model Number: 302-30
• Device Lot Number: 200556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2007
• 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: 32 YR