MAUDE Adverse Event Report: CYBERONICS, INC. OULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/08/2016

Event Type  Injury  

Event Description

The nurse practioner is referring patient for full revision due to migration.Replacement was stated to be necessary because patient's current vns has migrated to the edge of the chest wall, rendering access very difficult.No known surgical interventions have occurred to date.Additional relevant information has not been received to date.

Event Description

Additional information was received that the device migration occurred between visits in (b)(6) 2016 and (b)(6) 2017.There are no known causes for the migration such as trauma or manipulation.Surgical intervention is planned to preclude a serious injury.The previous implant surgeon confirmed that a non absorbable suture was used to secure the generator to fascia during the implant.No known surgery has occurred to date.

Event Description

Patient underwent surgery for generator and lead replacement.The explanted devices have not been received to date.

Manufacturer Narrative

(b)(4).

Event Description

The explanted generator and lead were received.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There are no performances or any other type of adverse conditions found with the pulse generator.Analysis of the lead is underway but has not been completed to date.

Event Description

Analysis of the received lead was completed.The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.What appeared to be white deposits were observed in various locations.Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed on the deposit observed on the unmarked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The set screw marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device.

• Brand Name: OULSE GEN MODEL 104
• 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: 6455535
• MDR Text Key: 71576323
• Report Number: 1644487-2017-03557
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2013
• Device Model Number: 104
• Device Lot Number: 201862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 48 YR