MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Fracture (1260); Malposition of Device (2616)

Patient Problems Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

Patient experienced discomfort and pain at the generator site since her generator replacement surgery.It was also noted that the generator is placed sub-pectorally when the patient was young, which is causing pain for the patient currently.Patient was referred for a revision surgery to help ameliorate the pain and for easier interrogation.Additional information was received that the patient thinks that the generator placement is too close to the skin and finds it irritating since the surgery in (b)(6) 2015.The pain is associated with he presence of generator and not related to vns stimulation.Patient is pursuing further surgery to change position of vns placement.No problems were reported with the vns device other than patient's dissatisfaction with the generator placement from the previous surgery.Patient underwent surgery on (b)(6) 2015.Per the surgeon, the lead was fractured in several places and was removed.A new lead was not implanted.It is unknown if the generator was left in or if the pocket was revised.A lead revision surgery is planned but attempts for additional relevant information were unsuccessful.The explanted device was not received for analysis to date.

Event Description

The explanted lead was reported to have been discarded.Patient's generator was explanted prophylactically on (b)(6) 2015 and patient was implanted with a new generator and lead.The explanted generator has not been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5208310
• MDR Text Key: 31015971
• Report Number: 1644487-2015-06365
• 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,Followup
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2003
• Device Model Number: 300-20
• Device Lot Number: 2656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2001
• 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: 29 YR