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

Device Problem High impedance (1291)

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

Event Date 02/27/2014

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance.The generator was programmed off and the patient was referred for x-rays.The patient may be referred for surgery.No known surgical intervention has been performed to date.

Manufacturer Narrative

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

Manufacturer Narrative

The previously submitted mdr inadvertently provided the wrong evaluation codes.

Event Description

It was reported that through the programming history database periodic review high impedance occurred on vns patient's generator model 102 serial number (b)(4).

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.

Event Description

X-rays dated on (b)(6) 2015 were provided to the manufacturer for further review.The generator appears in the right chest in an abnormal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.

Manufacturer Narrative

The previously submitted mdr inadvertently provided an incorrect gender.The previously submitted mdr inadvertently provided an incorrect event date.The previously submitted mdr inadvertently provided an incorrect event description.The previously submitted mdr inadvertently provided an incorrect data.

Event Description

The available programming history data of the patient¿s device (model 102 sn (b)(4)) was reviewed.The data was observed from (b)(6) 2013 through (b)(6) 2014.The device was last programmed on (b)(6) 2014 to 8% duty cycle.The last parameters recorded were 0 ma/20hz/250¿s/21sec/5min and magnet mode was1.25 ma/21sec/250¿s.Diagnostic data was also found.Last diagnostic recorded was on (b)(6) 2014.The lead impedance was high (dcdc 7) and eri no.The parameters data also indicated that the stimulation ok.The review of the available programming history revealed high impedance observed on (b)(6) 2014.

• Brand Name: LEAD MODEL UNK
• 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: 4427254
• MDR Text Key: 16854555
• Report Number: 1644487-2015-03645
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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