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

Model Number 302-20

Device Problems Break (1069); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

It was reported that the vns patient was referred for surgery due to a depleted battery and lead break.It is unclear how the lead break was determined, but it was attributed to the patient¿s recent mammogram that damaged her device.The date of the mammogram is unknown.The patient presented with pain in her left chest and neck on (b)(6) 2014 following the issue with the mammogram.The patient did not experience any pain related to vns prior to the mammogram.The patient¿s device was disabled and the patient did not have symptoms since the device disablement.The patient stated that the generator had migrated further down towards the axilla aggravating the incision scars.The physician noted that the incision sites appeared normal.The patient¿s device did not show any issues with the device.An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2014 due damage from the mammogram.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the returned generator and lead was completed.There were no anomalies found with the pulse generator.There were no observed product-related anomalies with the single returned lead portion.Radiographic examination of the connector pin (negative coil) and ring (positive coil) shows the ends of the coils at the crimp locations.Although not conclusive, it is believed that the coils were torn at crimp locations most likely at explant.

Event Description

Information received on 05/17/2016 for file (b)(4) regarding the patient's post-op nerve damage, states that the patient did have a broken lead after mammogram and underwent a full replacement because of it which was previously reported.

• 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: 4168428
• MDR Text Key: 4874860
• Report Number: 1644487-2014-02679
• 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,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2009
• Device Model Number: 302-20
• Device Lot Number: 200364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2006
• 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