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

Model Number 300-20

Device Problem High impedance (1291)

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

Event Date 01/26/2015

Event Type  malfunction  

Event Description

Analysis of the generator explanted (b)(6) 2015 was completed, and is captured in manufacturer report # 1644487-2014-03067.The downloaded data from this generator showed that the date of high occurrence occurred sometime before (b)(6) 2015, as the impedance value changed from 13139 ohms to 22903 ohms on that day.Additional information was received that the patient underwent generator and lead replacement surgery (b)(6) 2015 due to prophylactic generator replacement and high impedance.The explanted products were received for analysis.Analysis of the explanted generator was completed.There were no performance or any other type of adverse conditions found with the pulse generator.The last recorded 25% change in impedance was from 12935 ohms to 3957 ohms on date of implant, (b)(6) 2015.Analysis of the lead has not been completed to date.

Manufacturer Narrative

Event description; corrected data: the previously submitted mdr inadvertently failed to include information that the patient received generator and lead replacement surgery (b)(6) 2015.Date of explant; corrected data: the previously submitted mdr inadvertently failed to indicate the date of explant.

Event Description

It was reported that during generator replacement surgery on (b)(6) 2015 due to low output current, the vns patient¿s replacement generator was tested with the existing lead and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms).The replacement generator was tested with a test resistor and generator diagnostic results showed lead impedance within normal limits (impedance value ¿ 3900 ohms).The lead pin was reinserted into the generator header but the high impedance condition did not resolve.There was no indication that the lead was damaged during the procedure.Preoperative diagnostic tests were not performed.The lead was not replaced during the procedure.No known surgical interventions for the high impedance condition have occurred to date.The low output current event was reported in manufacturer report # 1644487-2014-03067.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Analysis of the explanted and returned lead was completed.Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Except for slight observed pitting on connector pin(s) and typical wear and explant related observations, there were no observed product related issues with the returned lead portions.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies.Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 4531831
• MDR Text Key: 20144554
• Report Number: 1644487-2015-03916
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2001
• Device Model Number: 300-20
• Device Lot Number: 20423C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 02/20/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/20/2015; 04/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/1999
• 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: 37 YR