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

Model Number 300-20

Device Problem High impedance (1291)

Patient Problems Fall (1848); Hypoesthesia (2352)

Event Date 03/01/2015

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance (> 10,000 ohms).It was reported that a second diagnostic test was performed which was within normal limits.A third diagnostic test was performed with the patient's head turned which resulted in another high impedance reading indicating a possible intermittent lead break.The device was programmed off and the patient was referred for surgery.It was reported that the patient suffered a fall against a cabinet on (b)(6) 2015 where the patient hit the cabinet pretty hard.The patient suffered another fall in (b)(6) that resulted in an emergency room visit.It was later reported that the patient wants to hold off on lead replacement surgery since the patient has experienced a dramatic decrease in seizures since (b)(6).The patient wants to wait and see what happens.

Manufacturer Narrative

(b)(4): device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

It was reported that the patient's device was programmed back on during a recent clinic visit.The physician ran a system diagnostic test, which returned an impedance value within the normal limits.The physician later reported that he did not perform diagnostics in multiple positions during the clinic visit.The physician reported seeing an impedance value that indicated high impedance, but stated that impedance was ok during both system and normal mode diagnostic testing.No additional relevant information has occurred to date.No surgical intervention has occurred to date.

Event Description

The patient reported that he no longer felt magnet stimulation during his daily morning swipe when the high impedance was initially identified.The patient also reported experiencing a slight tingling sensation at his generator site.No additional relevant information has been provided 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: 4812080
• MDR Text Key: 5892388
• Report Number: 1644487-2015-04824
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• 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: 4920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2002
• 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 Outcome(s): Other
• Patient Age: 58 YR