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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Paralysis (1997)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

Further follow-up with the physician revealed that the patient did not have vocal cord paralysis when the patient was seen and the device was off.The physician does not suspect that the vocal cord paralysis is related to the high impedance.The physician reported that the high impedance was first observed on (b)(6) 2014 (9950 ohms) and the device was programmed off.The patient denies manipulation that may have caused the high impedance; however, the physician reported that the patient is known as a manipulative character.The physician indicated that he is not recommending the patient undergo replacement surgery at this time because the current symptoms are not chronic depression but are character disorder.No other relevant information has been received to date.

Event Description

It was reported that the patient's vocal cord is frozen, but that the patient is used to it.It was reported that the patient developed vocal cord paralysis in 2014 and it was attributed to vns stimulation.It was reported that the voice alteration was not observed with the patient.The patient's last known vns physician indicated that device diagnostics on (b)(6) 2014 were within normal limits and device settings were changed.No additional relevant information has been received to date.The patient was seen by a new vns physician and reported that device diagnostics resulted in high impedance.It was reported that the patient has been referred for surgery.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

Event Description

Additional information was received stating that the vns patient was seeing a new psychiatrist who believes that the patient has depression.No known surgical interventions have occurred to date.

Event Description

New information was received indicating that the patient feels her devices have migrated.The patient stated that she believes the device is "dead" but it is unknown at this time if this is referring to the prior device disablement or a belief that the device battery has depleted.The patient has contacted a surgeon to discuss explant of her devices.The surgeon has asked for her device to be interrogated before proceeding further.Attempts to obtain additional relevant information have been unsuccessful to date.No known surgical interventions have occurred to date.

Event Description

An implant card was subsequently received indicating that the patient had undergone full system revision on (b)(6) 2016 due to high lead impedance.The high impedance condition (>=10,000 ohms) was verified in the operating room the day of the revision procedure.Impedance was noted to be normal with the newly implanted generator and lead.The explanted devices were discarded by the explanting facility.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the surgeon does use nurlon sutures if the case is subcutaneous procedure to secure the generator.Most of his cases are subpectoral and this is such a tight fit that he typically doesn't suture down.It is the surgeon's preference.

• 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: 4119327
• MDR Text Key: 5108253
• Report Number: 1644487-2014-02477
• 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,Followup
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2005
• 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): Other
• Patient Age: 52 YR