MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 300

Model Number 300-20

Device Problem Fracture (1260)

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

Event Date 03/22/2017

Event Type  malfunction  

Event Description

During a patient's generator replacement surgery, the surgeon unscrewed the two lead pins and attempted to remove them from the patient's device; however, the positive lead pin would not come out of the generator.When the surgeon pulled on the positive lead pin to remove it, the lead wire detached from its silicone casing, breaking the lead.It was later reported that the patient underwent full revision surgery.The patient's explanted devices were discarded and are unavailable for analysis.The device history record of the lead was reviewed, and the lead met all specifications for release.No additional relevant information has been provided.

• Brand Name: LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6503930
• MDR Text Key: 73234241
• Report Number: 1644487-2017-03642
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2000
• Device Model Number: 300-20
• Device Lot Number: 6280C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/1997
• 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: 37 YR