MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pocket Erosion (2013)

Event Date 01/30/2015

Event Type  Injury  

Event Description

It was reported that the vns patient¿s lead was protruding through the patient¿s skin.Patient manipulation is not believed to have caused or contributed to the protrusion.Operative notes were received indicating that the patient¿s lead was well incorporated into the patient¿s skin at the previous generator replacement surgery on (b)(6) 2012.The patient underwent generator and lead replacement surgery on (b)(6) 2015.The notes indicate that at least two loops of the lead were protruding from a defect in the skin of the left neck.There was no pus, erythema, fever or chills.The explanted devices have been returned to the manufacturer where analysis is currently underway.

Event Description

Product analysis for the lead completed on 3/12/2015.Scanning electron microscopy of the positive and negative lead coils show that pitting or electro-etching conditions have occurred on the coil surfaces.The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads).Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Event Description

The analysis was completed on the patient's explanted generator.The explanted lead analysis is pending completion.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 4542004
• MDR Text Key: 5541415
• Report Number: 1644487-2015-03964
• 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,Followup,Followup
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2001
• Device Model Number: 300-20
• Device Lot Number: 27396C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/1999
• 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: 69 YR