MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL

Model Number 300-20

Device Problem Device Expiration Issue (1216)

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

Event Date 10/24/2016

Event Type  malfunction  

Event Description

The patient was referred for generator replacement surgery due to battery depletion.The generator was reportedly at end of service for almost 10 years therefore pre-op diagnostics could not be performed.It was reported that during the surgery the surgeon observed a discontinuity in the sheath of the lead.The inner and outer tubing of the lead were abraded however the lead wires appeared to be intact.The surgeon decided to replace the lead and generator at that time.The explanted lead has not been received to date.

• Brand Name: BIPOL LEAD MODEL
• 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: 6109125
• MDR Text Key: 60552624
• Report Number: 1644487-2016-02660
• 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
• Report Date: 10/24/2016

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: 01/31/2001
• Device Model Number: 300-20
• Device Lot Number: 19504C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/1999
• 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: 36 YR