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

Model Number 300-20

Device Problems Fracture (1260); High impedance (1291); Battery Problem (2885); Moisture or Humidity Problem (2986)

Patient Problem No Code Available (3191)

Event Date 02/18/2016

Event Type  malfunction  

Event Description

During a generator replacement for battery depletion, high impedance was observed when the existing lead was connected to the new generator.Interrogation of the existing generator prior to surgery was unsuccessful despite multiple attempts due to the generator battery being depleted.During the surgery, the surgeon visible saw a lead fracture below the anchor tether and also noted fluid in the lead.Therefore the lead was also replaced.Diagnostics were within normal limits after the revision surgery (dcdc-1).The explant facility do not return the explanted products back to the manufacturer.

• 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: 5495038
• MDR Text Key: 40434701
• Report Number: 1644487-2016-00529
• 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: 02/18/2016

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: 02/29/2004
• Device Model Number: 300-20
• Device Lot Number: 5262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/11/2016
• Date Device Manufactured: 02/13/2002
• 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: 33 YR