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 03/11/2014

Event Type  malfunction  

Event Description

Additional information from the treating physician revealed there had been no patient manipulation or trauma that could have contributed to the high lead impedance results.Diagnostics from (b)(6) 2012 and (b)(6) 2013 were noted to be ¿unremarkable¿ by the physician.

Manufacturer Narrative

Relevant tests/laboratory data, including dates, corrected data: previously submitted mdr inadvertently omitted the high impedance value.

Event Description

It was reported that device diagnostics during generator replacement resulted in high impedance.It was reported that the high impedance was discovered pre-operatively and that both the lead and generator were replaced.The surgeon reported that there was fluid in the lead insulation when the lead was explanted.It was reported that the high impedance was not know prior to surgery.There is no trauma or patient manipulation known that may have caused or contributed to the high impedance.It was reported that the explanting facility discarded the explanted devices and they would not be returned for analysis.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3734823
• MDR Text Key: 4393739
• Report Number: 1644487-2014-00932
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2007
• Device Model Number: 302-20
• Device Lot Number: 011503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2005
• 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: 56 YR