MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Mechanical Problem (1384); Low impedance (2285)

Patient Problem Pain (1994)

Event Date 01/01/2013

Event Type  malfunction  

Event Description

It was reported that low impedance was detected on the patient's generator on (b)(6) 2018.The patient's lead impedance had been demonstrating a gradual, sustained decrease over time since approximately 2013.The patient had no trauma or falls expected to have contributed to this event.At the time of the detection of low impedance, he patient reported that she sometimes felt painful stimulation in the chest area.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that the patient underwent lead and generator replacement due to low impedance.The suspect product was received but product analysis on the device has not been completed to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned lead.There were no conditions observed in the returned portions of lead that could potentially contribute to the reported low impedance.Note that because a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.Multiple abraded openings were noted in the outer tubing.The condition of the returned lead portions was consistent with those that typically exist following an explant procedure.No obvious anomalies were noted.Product analysis was completed on the returned generator.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.The device was monitored for 24 hours in a simulated body temperature environment.The generator provided the expected output signal the entirety of the 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.

• Brand Name: LEAD MODEL 304
• 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: 7304315
• MDR Text Key: 101271405
• Report Number: 1644487-2018-00301
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 304-20
• Device Lot Number: 2954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 03/22/2018; 04/20/2018
• Supplement Dates FDA Received: 04/16/2018; 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2011
• 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 Age: 23 YR