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

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

Patient Problem No Code Available (3191)

Event Date 11/03/2016

Event Type  malfunction  

Event Description

It was reported that the patient's device showed high impedance.The device was programmed off and patient was referred for lead revision and prophylactic generator replacement.Patient's mother reported that the patient's seizure activity has increased every day since device has not been working.No additional relevant information has been received to date.No known surgical interventions have occurred to date.

Event Description

Patient underwent full revision surgery.The surgeon believes the single incision technique used during the initial implant surgery may have contributed to the lead break.The explanted lead was received.Analysis is underway but has not been completed to date.

Event Description

A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.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 outer silicone tubing 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 setscrew marks found on the lead connector pin 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 discontinuities in the returned portion of the device.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 6130470
• MDR Text Key: 61248283
• Report Number: 1644487-2016-02740
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/24/2017; 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 10 YR