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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 09/03/2015

Event Type  malfunction  

Event Description

It was reported that high impedance was observed on vns patient's system.It was reported that the patient, who had good seizure control with the vns, experienced an increase in seizures and pain around his voice box.The patient was seen to the clinic on (b)(6) 2015 where his device was interrogated and showed high lead impedance.It was reported that the device was switched off.X-rays were taken but no obvious lead break was seen.Those x-rays were not sent to the manufacturer for review.It was reported that the device was again interrogated on (b)(6) 2015 and high impedance results persisted (>=10000 ohms).The device was then left switched off.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.No known surgical interventions have been performed to date.

Event Description

Further information was received indicating that the patient underwent revision surgery on (b)(6) 2015.The suspect lead was explanted and a replacement lead was implanted.No additional relevant information was provided to date.

Event Description

Further information was received from a nurse indicating that the explanted lead was discarded by the facility.Therefore, analysis cannot be performed.

• 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: 5204037
• MDR Text Key: 30733015
• Report Number: 1644487-2015-06350
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2012
• Device Model Number: 302-20
• Device Lot Number: 2309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2009
• 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: 32 YR