MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems High impedance (1291); Positioning Problem (3009)

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

Event Date 04/08/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device showed high impedance.The patient was re-positioned and the device was retested, but the device continued to show high impedance.Patient manipulation or trauma is not believed to have caused or contributed to the high impedance.The device was only disabled to take x-rays.X-rays dated (b)(6) 2014 were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin does not appear to be fully inserted into the generator connector block.The electrodes appeared to be placed in normal arrangement.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.Based on the images provided, the cause of the high lead impedance is likely due to incomplete lead pin insertion.No known surgical interventions have occurred to date.

Event Description

Additional information was received stating that the vns patient complained of severe pain in his left neck area during an office visit on (b)(6) 2014.The patient¿s device was tested during the office visit and diagnostic results showed high impedance.The patient was sent for x-rays and the radiologist noted a lead break in the lead portion near the generator; however, the neurologist stated that he was unable to observe any lead discontinuities in the x-ray images.The patient¿s device was disabled and the patient was referred for surgery.No known surgical interventions have occurred to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of x-rays by the manufacturer revealed incomplete lead pin insertion.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• 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: 3863988
• MDR Text Key: 4565325
• Report Number: 1644487-2014-01451
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: 105
• Device Lot Number: 202722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2013
• 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: 38 YR