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

Device Problems High impedance (1291); Device Inoperable (1663); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 06/13/2016

Event Type  malfunction  

Event Description

It was reported that the patient was referred for a battery replacement due to the battery being at end of service.During pre-op, high impedance was observed during a diagnostic test.Surgery was postponed due to the patient eating prior to the surgery.X-rays were performed and reviewed by the manufacturer.The x-rays showed that the lead connector pin appeared to not be fully inserted.It was also noted that the lead was not placed per labeling.The strain relief bend was present but it was not secured by a tie down.There was not a sufficient strain relief loop and there were no tie downs present.Additionally, a portion of the lead near the electrodes could be not fully assessed.Therefore a potential lead fracture could not be ruled out in this portion of the lead.The surgery was rescheduled.During the surgery the lead pin was fully inserted into the generator and diagnostic testing was performed.The high impedance did not resolve after the pin re-insertion.The lead and generator were then replaced and the surgeon found a lead fracture near the anchor tether.The explanted lead and generator were disposed of following surgery.Therefore product analysis cannot be completed.

Event Description

It was reported that during the lead and generator replacement surgery the surgeon connected the existing lead with the new generator.The lead connector pin was fully inserted and the diagnostic tests were run which resulted in high impedance.The surgeon then proceeded to replace the lead.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 5779309
• MDR Text Key: 49906751
• Report Number: 1644487-2016-01536
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 18 YR