MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNK; GENERATOR

Model Number 106

Device Problem High impedance (1291)

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

Event Date 09/14/2015

Event Type  malfunction  

Event Description

It was reported that system diagnostics run on the patient's vns device returned high impedance immediately after suturing the incisions of the implant surgery.X-rays were taken and review by the healthcare professionals determined that the lead-pin was not fully inserted into the generator's connector block.X-rays review by the manufacturer found that the generator was in the upper left chest in a normal placement.The filter feed-through wires appeared to be intact.The lead connector-pin was not fully inserted into the generator connector block.The electrodes appeared to be placed in normal arrangement.There was lead behind the generator.No lead breaks or sharp bends were found in the visible parts.The lead wires appeared to be intact at the connector pin.It was reported that the patient underwent surgical intervention one day after the implant for lead-pin re-insertion.Once completed, the impedance of the vns system was found to be normal.No device was explanted.

Manufacturer Narrative

(b)(4).The suspect device udi was inadvertently not provided in the initial mdr.Sex of patient; corrected data: the previously submitted mdr inadvertently provided an incorrect patient sex.Model #, lot # and expiration date; corrected data: the previously submitted mdr inadvertently provided the incorrect information for the device.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• 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: 5136335
• MDR Text Key: 28161709
• Report Number: 1644487-2015-06055
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2017
• Device Model Number: 106
• Device Lot Number: 4309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/02/2015
• 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
• Patient Age: 28 YR