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

Model Number 302-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Muscle Spasm(s) (1966); Pain (1994); Anxiety (2328); Discomfort (2330)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.Further follow-up revealed that the patient underwent surgery for patient comfort and not to preclude a serious injury.Patient manipulation or trauma is not believed to have caused or contributed to the lead discontinuity.The patient¿s pain was occurring with stimulation and due to lead discontinuity.The explanted products have not been returned to date.

Event Description

The patient¿s pain was occurring with stimulation and due to lead discontinuity.The lead discontinuity is likely due to a short circuit situation (dcdc code = 0).

Event Description

Surgical notes dated (b)(6) 2014 indicated that the vns was malfunctioning and that the patient underwent generator and lead replacement.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.Adverse event and/or product problem; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain.Brand name; corrected data: additional information indicates that the suspect device is the lead.Type of device, name; corrected data: additional information indicates that the suspect device is the lead.Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the lead.Type of reportable event; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain.Device manufacture date; corrected data: additional information indicates that the suspect device is the lead.

Event Description

It was reported that the vns patient was experiencing very painful side-effects from vns.Further follow-up with the patient revealed that the patient was experiencing pain on the left side of her neck that radiated up to her temple.This mostly occurred through the patient¿s jaw and roof of her mouth causing headaches.The patient was most uncomfortable at night and when she was lying down.The patient later reported that the pain was getting worse and that she was feeling sick and panicking.The patient¿s device was eventually programmed off on (b)(6) 2014 despite it being effective in treating the patient¿s depression.The patient was referred for generator and lead replacement surgery due to severe headaches and neck spasms.The patient¿s normal mode output current was programmed off and system diagnostic results showed normal device function.No known interventions have occurred to date.

Manufacturer Narrative

Manufacturer Narrative

Describe event or problem, corrected data: this information (spasms, fatigue, nausea) was inadvertently not included in the initial mfr.Report.Describe event or problem, corrected data: this information (pain, coughing) was inadvertently not included in the mfr.Supplement report #3.Additional manufacturer narrative, corrected data: mfr.Supplemental report #2 should have included the description of the corrected data as "describe event or problem, corrected: this information was inadvertently not included in the initial mfr.Report.".

Event Description

It was reported that the patient experienced abdomen and chest spasms, fatigue and nausea.The patient experienced pain and coughing at the time of device interrogation.

• 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: 3808957
• MDR Text Key: 4510151
• Report Number: 1644487-2014-01246
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2005
• 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: 49 YR