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

Model Number 302-20

Device Problem Low impedance (2285)

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

Event Date 01/08/2014

Event Type  malfunction  

Event Description

During the patient's vns generator replacement, it was found that system diagnostic tests showed low impedance.The test was repeated with the same results.The surgeon reseated the lead pin and a third test was run, but the same results were obtained.Follow up found that there were no x-rays planned or taken.The patient's family did not report any trauma or manipulation that would have contributed to the impedance.No interventions have been planned, as the physician plans to observe the patient clinically.No other information was provided.

Event Description

On (b)(6) 2014, it was reported that the patient was doing well and diagnostics continued to show low impedance.Review of converted programming and diagnostic data from the date of surgery showed that with the newly implanted generator, four system diagnostic tests were with repeated low impedance results (35 ohms, 21 ohms, 21 ohms, 21 ohms).The explanted generator was also interrogated: data shows that a normal impedance value was stored from the internal check on (b)(6) 2014 (2313 ohms).A subsequent system diagnostic on (b)(6) 2014 continued to show low impedance: 21 ohms.The device remained programmed on.No interventions have been taken to date.

Event Description

On (b)(6) 2015, the patient went for a routine device check.Low impedance and a possible lead discontinuity were indicated.Company representative reported on (b)(4) 2015 that x-rays were taken and there was no visible lead break.

Manufacturer Narrative

Device manufacturing records and programming history were reviewed.Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Analysis of converted programming history.

Event Description

The patient received a lead revision.A company representative reported that the lead was broken.The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

• 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: 3602012
• MDR Text Key: 4161522
• Report Number: 1644487-2014-00332
• 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: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2010
• Device Model Number: 302-20
• Device Lot Number: 1955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2007
• 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: 21 YR