MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Moisture Damage (1405); Pitted (1460); Low Battery (2584); Naturally Worn (2988); Scratched Material (3020)

Patient Problem No Code Available (3191)

Event Date 10/01/2011

Event Type  malfunction  

Event Description

It was reported that the patient underwent generator and lead explant surgery due to low battery and lead pulling sensation on (b)(6) 2015.The explanted generator and lead were received by the manufacturer for analysis.Analysis of the generator in the analysis lab concluded that no abnormal performance or any other type of adverse condition was found, other than normal battery depletion.Analysis of the lead, on the other hand, showed pitting or electro-etching conditions have occurred on the unmarked connector pin surface.Abraded openings and fluid leaks were observed in the outer silicon tubing.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

• Brand Name: BIPOL 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: 5330996
• MDR Text Key: 35033710
• Report Number: 1644487-2015-06842
• 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: 12/04/2015

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: 01/31/2004
• Device Model Number: 300-20
• Device Lot Number: 5131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2002
• 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