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

Model Number 304-20

Device Problem High impedance (1291)

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

Event Date 03/05/2014

Event Type  malfunction  

Event Description

It was reported that the lead has been discarded.Analysis of the generator was completed.Review of the internal data shows a change in impedance occurred approximately on (b)(6) 2014 from 2131 ohms to >20000 ohms.Results of diagnostic testing indicated that the battery status indicated ifi=yes in the analysis lab, the battery is partially depleted.Electrical test results showed that the pulse generator performed according to functional specifications.There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Manufacturer Narrative

Evaluation, correction: it was inadvertently not reported on supplemental report #1 that the lead was discarded.

Event Description

It was reported that during prophylactic generator replacement surgery on (b)(6) 2014, the replacement generator was tested with the existing lead and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms).Operative notes stated that the surgeon did not observe any breaks in the lead or any leakage through the insulation at the chest wall pocket portion of the lead.The patient¿s device was not programmed on during the procedure.The operative notes indicate that diagnostics were performed after the patient was closed; therefore, no intraoperative troubleshooting was performed.Notes were received showed normal diagnostic results through (b)(6) 2013.X-rays were taken and were reported in the notes to be unremarkable.No known interventions have occurred to date.Attempts for additional relevant information were made but have been unsuccessful to date.

Event Description

The patient underwent lead replacement surgery.The explanted generator was returned for analysis; however, despite attempts to have the lead returned for analysis, the lead has not been received to date.Attempts to obtain additional relevant information have been unsuccessful to date.Generator analysis is underway, but has not been completed to date.

Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3740315
• MDR Text Key: 4567590
• Report Number: 1644487-2014-00802
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2014
• Device Model Number: 304-20
• Device Lot Number: 2727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2010
• 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