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

Model Number 105

Device Problems Fracture (1260); High impedance (1291)

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

Event Date 03/16/2015

Event Type  malfunction  

Event Description

Additional information was received that the patient's vns system was explanted due to death (b)(6) 2015.The death is not thought to be related to vns.Additional information was received that high impedance was not seen for this patient during initial implant.Also, the patient's device was not disabled following high impedance observation.Review of manufacturing records confirmed that the generator and lead passed all functional tests prior to distribution.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

Event Description

It was reported that device diagnostics resulted in high impedance.No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance.It was reported that device diagnostics were within normal limits during implant.X-rays were taken and sent to manufacturer for review.Review of x-rays did not identify any obvious discontinuities with the vns system.The presence of a micro-fracture could not be ruled out.

Manufacturer Narrative

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

Event Description

The explanted generator and lead have been received by the manufacturer for analysis.However, analysis has not been completed to date.

Event Description

Analysis was completed on the explanted generator and lead.Analysis of the generator showed no anomalies.The device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications analysis of the lead showed a set of setscrew marks near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator.The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead.X-ray suggests canted spring was marginally connected to the connector ring.Canted spring indentations were observed on the rear end of the small front o-ring.During the visual analysis of the returned 373mm portion the (+) white and (-) green electrode ribbons were observed to be embedded in what appeared to be remnants of dried body tissue.This condition may have prevented the electrode ribbons from coming in contact with the vagus nerve.With the exception of the observed tissue-covered electrode ribbons and the set of setscrew marks observed near the end of the connector pin the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.

• Brand Name: PULSE GEN MODEL 105
• 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: 4673669
• MDR Text Key: 5778479
• Report Number: 1644487-2015-04426
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/22/2016
• Device Model Number: 105
• Device Lot Number: 4022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• 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: 9 YR