MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291); Difficult to Insert (1316)

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

Event Date 08/26/2014

Event Type  malfunction  

Event Description

It was reported that during surgery for high impedance on (b)(6) 2014 (mfr.Report # 1644487-2014-01301), a new generator was connected to the lead which resulted in device diagnostics within normal limits (impedance value 3470 ohms).It was determined that the prior high impedance measurement was due to a lead pin insertion issue, so the existing lead was left in place.The next day, (b)(6) 2014, the patient's device was programmed on.System diagnostics were run, and the impedance was 2764 ohms.The patient was seen for follow-up on (b)(6) 2014.System diagnostics were performed, and the impedance was greater than 10,000ohms.It was advised that a likely intermittent lead fracture existed and the lead should be replaced.No known surgical intervention has been performed to date.No additional relevant information has been received to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

• 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: 4164299
• MDR Text Key: 4786313
• Report Number: 1644487-2014-02423
• 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: Physician
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2005
• 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: 22 YR