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

Model Number 302-20

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Anxiety (2328); Discomfort (2330)

Event Date 05/13/2014

Event Type  Injury  

Event Description

Additional information was received stating that the vns patient underwent surgery for patient comfort and not to preclude a serious injury.The patient was a non-responder to vns therapy; therefore, the patient¿s generator was explanted and not replaced.Analysis of the returned generator and lead was completed.Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.The device performed according to functional specifications.Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time.The connector pin was inserted into the cavity of a test generator to verify a dimensional issue in the connector portion of the lead wasn¿t preventing the connector pin from being fully inserted into a generator.No obstructions were noted.The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead.However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring.Canted spring marks were not observed on the rear end of the small o-ring.Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.Based on the findings, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints.Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description

It was reported that the vns patient was referred for surgery to explant his device due to discomfort and pain from a lead pulling sensation whenever he turned his head.The patient¿s device was disabled in 2011 due to lack of efficacy in treating the patient¿s depression.It was later determined that the patient did not have depression but was suffering from an anxiety disorder.The patient¿s generator and lead were explanted on (b)(6) 2014.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3854239
• MDR Text Key: 4577004
• Report Number: 1644487-2014-01424
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/13/2014

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/17/2014
• Initial Date FDA Received: 06/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2006
• 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): Required Intervention
• Patient Age: 60 YR