MAUDE Adverse Event Report: CYBERONICS LEAD MODEL UNK

Device Problems Break (1069); Corroded (1131)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported through letter received that lead was explanted due to lead break.The explanted lead was washed, disinfected and was sent the manufacturer.The physician requested to analyze the lead to check the suspected fracture of lead.It was reported that this lead was implanted in (b)(6) 2008.The returned explanted lead was received by the manufacturer for the analysis; it was no possible to identify the model and serial number due to the partial lead return.The analysis was completed and this confirmed the discontinuity of both positive and negative coils in the electrode region of the returned lead portions; an abraded inner tubing opening near the coil break was observed.Abraded opening was also found on the outer silicone tubing and the cut ends that were made during the explanted process.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on the coil surface during the testing.

• Brand Name: LEAD MODEL UNK
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 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: 5965905
• MDR Text Key: 55627145
• Report Number: 1644487-2016-02150
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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