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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2017

Event Type  malfunction  

Event Description

The patient was seen at an office visit where it was noted that the lead impedance was high.There was no known trauma that may have contributed to the high impedance.X-rays were taken and evaluated by the physician.It was noted that no lead discontinuity was visualized.To date no surgical intervention has occurred.No other relevant information has been received to date.

Event Description

X-rays were received from the physician's office and were reviewed.It was noted that the lead pin may not have been fully inserted into the connector block from the images provided.A review of past diagnostics for the patient's device shows that the impedance was within a normal range as of (b)(6) 2015.

Event Description

The patient underwent lead revision.The explanted lead is suspected to be discarded as the explant facility does not have it.

• 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: 6358204
• MDR Text Key: 68363595
• Report Number: 1644487-2017-03247
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2011
• Device Model Number: 302-20
• Device Lot Number: 1985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2008
• 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 Age: 46 YR