MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 08/14/2014

Event Type  malfunction  

Event Description

During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed at office visit on (b)(6) 2014.It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance reading.It is unknown if surgery has been performed.The device was programmed off on (b)(6) 2014.The physician's office was notified of the high impedance event and the manufacturer's recommendations when high impedance is observed.No additional relevant information has been received to date.

Event Description

It was reported that the patient was experiencing pain in his left jaw, neck and shoulder during the visit when the high impedance was observed.The physician then disabled the device in response to the pain.Due to the diagnostic results observed during the visit, it appears that the pain was related to the lead fracture.No additional relevant information has been received to date.

Manufacturer Narrative

Corrected data: outcomes attributed to adverse event; this information was inadvertently left off on mfg.Report #1.

• Brand Name: LEAD MODEL 302
• 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: 5970450
• MDR Text Key: 55718368
• Report Number: 1644487-2016-02163
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2009
• Device Model Number: 302-20
• Device Lot Number: 1732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/24/2016; 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2006
• 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): Required Intervention
• Patient Age: 60 YR