MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problems Component Falling (1105); High impedance (1291); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Fatigue (1849); Pain (1994); Shaking/Tremors (2515); Shock from Patient Lead(s) (3162)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient was having issues with pain and with device migration.Clinic notes were received indicating that the patient had severe fatigue and tremors over the last two months.She later reported having a strange tremor in her head that occurred several times per day.It was noted that patient¿s device had migrated from its original position and was located at the wall of the axilla.Chest and neck x-rays were ordered because the patient reported occasional shocking sensations to the left side of the neck.The patient was instructed to temporarily disable her device with the magnet to determine whether her symptoms would subside.An implant card was received indicating that the patient underwent generator and lead replacement surgery due painful stimulation, shocking sensations and lead discontinuity.The patient¿s lead reportedly fell off the patient¿s vagus nerve and caused high impedance.The explanted generator and lead have not been returned to date.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

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

• 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: 4103125
• MDR Text Key: 4839861
• Report Number: 1644487-2014-02409
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2006
• Device Model Number: 302-20
• Device Lot Number: 010850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2004
• 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