MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-30

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Dyspnea (1816); Nerve Damage (1979); Therapeutic Response, Decreased (2271); Discomfort (2330); Numbness (2415)

Event Date 09/09/2011

Event Type  Injury  

Event Description

Analysis of the lead was completed on (b)(6) 2014.Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.

Event Description

On (b)(4) 2014, it was reported that the patient¿s generator and lead were explanted electively on (b)(6) 2014 as the patient reported no improvements to their seizure control since being implanted with the device and was experiencing some discomfort.The explanted lead and generator were returned for product analysis on (b)(4) 2014.The nurse later clarified that the discomfort the patient was feeling was in fact shortness of breath and numbness extending from the incision to the chin.The numbness was felt by neurosurgery to be due to injury to subcutaneous nerve during incision.The device had been disabled since (b)(6) 2012.The patient wanted the device off and refused parameter adjustment.The shortness of breath was due to device stimulation.It was stated that the explant surgery was not to preclude a serious injury.Diagnostics were not performed on the vns as the highest the patient was programmed to was an output of 0.75ma.No causal or contributory programming or medication changes preceded the onset of the events.The nurse stated that she believed vns was not programmed to more therapeutic parameters due to poor tolerance and therefore was not effective.Product analysis was completed on the generator on (b)(6) 2014.There were no performance or any other type of adverse conditions found with the pulse generator.Product analysis of the lead is still underway.

• Brand Name: LEAD MODEL 303
• 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: 3637198
• MDR Text Key: 4338393
• Report Number: 1644487-2014-00471
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2009
• Device Model Number: 303-30
• Device Lot Number: 200330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2006
• 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: 41 YR