MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL 200

Model Number 300-30

Device Problem Corroded (1131)

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

Event Date 01/01/2018

Event Type  malfunction  

Event Description

It was reported that the patient stated that device did not work for him and the patient did want to replace the battery.Follow up with the physician's office revealed that the vns did not change to patient's seizure frequency.The patient did not elect to replace the vns.However, the patient was referred for and underwent full vns replacement surgery due to an end of service condition and the lead compatibility with the new generator.The explanted lead was received by the manufacturer.Lead product analysis is completed.The lead assembly was returned in four portions.What appeared to be rust-like deposits and pitting were observed on the unmarked connector pin surface.Set-screw marks were observed and indicated that proper mechanical contact was present.Scanning electron microscopy, or sem, was performed and identified evidence of pitting and surface irregularities.Continuity checks of the returned lead portions were performed with no discontinuities identified.Based on the findings in the pa lab, there is no evidence to suggest an anomaly with the returned portions of the lead.No additional relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 200
• 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: 7923517
• MDR Text Key: 122314818
• Report Number: 1644487-2018-01735
• 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: Other
• Type of Report: Initial
• Report Date: 10/01/2018

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 Model Number: 300-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Event Location: Other
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/01/2018
• 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
• Patient Age: 31 YR