MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Device Inoperable (1663); Malposition of Device (2616)

Patient Problem Neck Pain (2433)

Event Date 07/24/2014

Event Type  Injury  

Manufacturer Narrative

Corrected data: the initial mfr.Report inadvertently reported the event as both serious injury and malfunction; however, this should only have been reported as a serious injury.

Event Description

It was reported that the vns patient was experiencing intense pain in her neck.The patient¿s device was subsequently disabled; however, the patient continued to experience stabbing pains but less frequently than before disablement.X-rays were taken and the lead reportedly appeared to be ¿unwrapped from the nerve.¿ the patient underwent generator and lead replacement surgery on (b)(6) 2014.The explanting facility discarded the explanted lead; therefore, no analysis can be performed.

Event Description

Additional information was received which stated the patient experienced neck pain prior to the revision surgery, even though the diagnostics were within limits.It was noted that when the lead was explanted fluid was found inside.After the revision surgery, the patient's neck pain didn't go away for the first few days after the surgery, but then it did resolve.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 4027949
• MDR Text Key: 12201812
• Report Number: 1644487-2014-02075
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2002
• Device Model Number: 300-20
• Device Lot Number: 255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2000
• 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: 19 YR