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

Model Number 302-30

Device Problem Battery Problem: High Impedance (2947)

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

Event Date 01/27/2014

Event Type  malfunction  

Event Description

It was reported that the patient underwent generator replacement surgery due to battery depletion and that high impedance was observed after the generator was connected to the existing lead.The explanted generator was completely depleted; therefore, high impedance was not observed prior to replacement.The patient did not undergo lead replacement at that time.The patient underwent lead replacement on (b)(6) 2016.The explanted lead was discarded therefore, no product analysis can be performed.

Manufacturer Narrative

The initial report inadvertently did not report the information about the scar.

Event Description

It was reported that the surgeon could not remove much of the old lead due to normal scar tissue as result of the healing process.Upon follow-up with the company representative that attended the surgery, it was reported that the lead pin was confirmed to be fully inserted into the generator header.The header was checked and appears to be free of obstruction and fluid during the surgery.There did not appear to be any visible damage to the explanted lead.Generator diagnostics with the replacement device were within normal limits which ruled out a generator issue.The lead was not replaced on (b)(6) 2016 because the patient had not approved prior to surgery to replace the lead.It was mentioned the patient had vocal cord damage from a prior vns implant surgery, as reported previously in mfg report #: 1644487-2004-00831.At that time, it was clarified that the surgeon had accidently hit the jugular vein, as reported in mfg report #: 1644487-2004-00831.No additional relevant information has been received.

Event Description

The company representative reported that the patient indicated that she had "damage" from a previous vns surgery.This is what was referred to in the previous report as "vocal cord damage." the damage was previously reported in mfg report #: 1644487-2004-00831.

Event Description

The explanted generator was received by the manufacturer.An end-of-service warning message was verified in the (b)(6) lab and found to be associated with the output being disabled by the pulse generator, due to the pulse generator remaining ¿on¿ post explant.In addition, review of the ram/flash data downloaded from the pulse generator shows an indication of pre-explant increased impedance; on approximately (b)(6) 2014, impedance had a 62;25% change of 7355 ohms to 9316 ohms, and the time of change detection (b)(6) 2014.No anomalies were identified with the performance of the generator and the device performed according to specifications.

• 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: 5817438
• MDR Text Key: 51292936
• Report Number: 1644487-2016-01676
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2004
• Device Model Number: 302-30
• Device Lot Number: 6736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2002
• 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 Age: 57 YR