MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Pain (1994)

Event Date 01/30/2016

Event Type  malfunction  

Event Description

It was reported that the patient铠lead experienced high impedance.He was scheduled for a full revision surgery.The patient also reported painful stimulation in the neck, and the device was disabled in relation to the high lead impedance.Surgery has not been reported to occur to date.Additional pertinent information has not been received to date.

Event Description

The patient's vns system was fully replaced on (b)(6) 2016.The impedance value of the replacement system was within normal limits.The explanting facility does not return explanted devices, so product return of the explanted generator or lead is not expected.No additional pertinent information has been received to date.

Event Description

The explanted generator and lead portion were received and underwent product analysis.It was noted that the lead was still inserted into the generator when it was received.A continuity check was performed on the lead and setscrew of the generator which verified proper contact between the lead pin and setscrew.Analysis on the lead found a kink in the lead coils however no discontinuities were identified in the returned portion of the lead.It was noted the portion of the lead with the electrode segment was not returned.Therefore it could not be evaluated and its role in the reported high impedance could not be determined.During analysis on the generator various impedance loads were attached to the generator and the subsequent diagnostic tests resulted in the accurate resistance measurements in all instances.The generator found that it performed to functional specification.The internal data of the generator was reviewed and noted the last >25% change in impedance occurred on (b)(6) 2016 when the prechange value was 2460 ohms and the postchange value was 11807 ohms.

• Brand Name: LEAD MODEL 302
• 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: 5639498
• MDR Text Key: 46080644
• Report Number: 1644487-2016-00976
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2016

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
• Device Expiration Date: 11/30/2004
• Device Model Number: 302-20
• Device Lot Number: 7416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/31/2016; 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2002
• 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: 40 YR