MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 300

Model Number 300-20

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

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

Event Date 01/01/2017

Event Type  malfunction  

Event Description

Surgery took place for this patient's.Full system revision due to battery depletion of the generator, and the need for a single pin lead necessary to be used with the new generator replacement.After surgery occurred, the products were returned and product analysis was completed.The generator showed an end of service condition, as a result of normal, expected battery depletion.Analysis of the lead revealed a coil break in the negative coil.Pitting or electro-etching conditions have occurred at the break locations.Due to metal dissolution, mechanical distortion and/or surface contamination, the fracture mechanism of the coil wires cannot be ascertained.No other anomalies were identified besides the typical wear and explant related observations.No other relevant information has been received to date.

• 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: 7026577
• MDR Text Key: 92797918
• Report Number: 1644487-2017-04768
• 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: 11/13/2017

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
• Device Expiration Date: 06/30/2000
• Device Model Number: 300-20
• Device Lot Number: 11845C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/1998
• 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: 40 YR