MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-30

Device Problem Fracture (1260)

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

Event Date 02/06/2017

Event Type  malfunction  

Event Description

It was reported that the patient was referred for generator replacement.Device diagnostics at the time were within normal limits.Prior to the intended replacement surgery, high impedance was registered on the patient¿s vns.The patient was reportedly not aware of a potential device issue as he had not experienced any associated adverse events.The surgery was not performed at that time.Surgical intervention to address the high impedance has not occurred to date, and no additional pertinent information has been received to date.

Event Description

The patient had surgery due to the high impedance.The lead pin was re-inserted into the generator, but the high impedance did not resolve.The physician then replaced both the generator and lead, which resolved the high impedance.The explanted products were not available from the hospital for return; therefore, no analysis could be performed.

• 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: 6375299
• MDR Text Key: 68970218
• Report Number: 1644487-2017-03301
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2010
• Device Model Number: 302-30
• Device Lot Number: 200588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2007
• 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: 33 YR