MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-30

Device Problem Low impedance (2285)

Patient Problems Undesired Nerve Stimulation (1980); Numbness (2415); No Code Available (3191)

Event Date 11/01/2004

Event Type  malfunction  

Event Description

It was reported by a nurse in the patient's group home that the patient was complaining that he felt electricity through his body on and off throughout the day.The patient also reported that his left arm felt heavy and numb.Follow up with the patient's neurologist revealed that the neurologist was unaware of the events.During review of the manufacturer's programming history database, it was revealed that a dcdc code of 0 was present during system diagnostics.The dcdc code, while possibly within normal limits, and the reported events are possibly indicative of low impedance.No additional information has been received to date.

Event Description

It was reported that the patient's mother felt that the vns had never really helped the patient with his seizures and that she did not want the vns replaced.It is unknown whether the lack of efficacy was related to the possible low impedance.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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7529711
• MDR Text Key: 108869502
• Report Number: 1644487-2018-00820
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2005
• Device Model Number: 302-30
• Device Lot Number: 8350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2003
• 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: 26 YR