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

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 10/06/2015

Event Type  malfunction  

Event Description

It was reported that vns system implanted in the patient was tested and system diagnostics returned high impedance with dcdc code 7 and neos no.X-rays were taken and sent to the manufacturer for review.The generator appears to be placed under the right arm in an abnormal arrangement.The filter feed-through wires appears to be intact.The insertion of the lead-pin connector could not be fully assessed due to the orientation of the generator in the x-rays and the quality of images, it appears to be not fully inserted.The electrodes appeared to be placed in abnormal arrangement, not in the neck.A strain-relief bend and a loop were not used.Only one tie-down was found holding the upper lead body.Part of the lead appeared to be behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.It was reported by the physician that the device was not switched off yet.No known surgical interventions have occurred to date.No patient adverse events were reported to date.

Event Description

Further information was received from the facility, indicating that the patient underwent full replacement surgery on (b)(6) 2016.The lead was replaced due to lead discontinuity and the generator was prophylactically replaced.Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.It was reported that the explanted devices will not be returned to the manufacturer as they were discarded.Therefore, no analysis results could be provided.No additional information was provided to date.

• 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: 5194237
• MDR Text Key: 30496295
• Report Number: 1644487-2015-06295
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

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: 11/30/2014
• Device Model Number: 302-20
• Device Lot Number: 2837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/06/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2010
• 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: 12 YR