MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 302

Model Number 302-20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Emotional Changes (1831); Muscle Spasm(s) (1966); Pain (1994); Visual Impairment (2138); Therapeutic Response, Decreased (2271); Discomfort (2330)

Event Date 03/26/2015

Event Type  Injury  

Event Description

It was reported that the vns patient had presented a sharp pain in the left side of the neck and pulling sensation.The patient did not perceive the stimulation and she could not indicate whether the pain occurred with stimulation or not.The settings were programmed at 1.5ma, 25hz, 130usec, 30secs on and 5mins off.The patient has dystonia and moves her neck quite a lot.X-rays were recommended but the patient did not wish to undergo any further surgical revision and preferred to have the generator disabled.Additional information was received indicating that the patient was implanted for depression.The pulse generator vns was disabled as the patient was experiencing severe discomfort.The patient wishes to undergo vns explant surgery because she believes that her cervical dystonia/torticollis is being worsened by vns.It was reported that the patient presented a severe pain episode caused by the lead, which seemed to be protruding more than it had done previously.It was reported that the patient also presented breathing difficulties, loss of some vision in one eye, severe pain in the middle of her back and abdominal pain which was relieved by the application of plasters.It was believed that these symptoms were related to the patient¿s depression.Surgical intervention for the explant of the vns system is expected but it has not occurred to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 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: 4804054
• MDR Text Key: 5928575
• Report Number: 1644487-2015-04792
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2014
• Device Model Number: 302-20
• Device Lot Number: 201322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2010
• 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: 61 YR