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

Model Number 302-20

Device Problems Fluid/Blood Leak (1250); Cut In Material (2454)

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

Event Date 10/14/2016

Event Type  malfunction  

Event Description

An implant card was received showing a full replacement for the patient during a prophylactic ifi replacement.Additional information was received from a company representative stating the reason the lead was replaced is the physician found the lead to have a cut in it during the replacement.The physician said that he did not cut the lead, therefore it seems to have been a pre-existing condition.He also said that the only pre-op diagnostic he saw was an ifi indicator.Per programming history date on (b)(6) 2016, diagnostics for the device were okay.Therefore the lead was likely functioning as intended up to the date of surgery and the patient was receiving intended therapy.The lead has not been received to date.

Event Description

The explanted lead was received on (b)(6) 2016.Analysis is underway, but hasn't been completed to date.

Event Description

Analysis was performed on the generator.The pulse generator performed according to functional specification.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

Analysis was performed on the lead assembly.An abraded opening was identified in the outer silicone tubing.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.No obvious point of entrance was noted other than the identified outer tubing openings (for outer tubing fluid ingress) and the cut end of the returned lead portions (for inner tubing fluid ingress).

• 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: 6082516
• MDR Text Key: 59722520
• Report Number: 1644487-2016-02578
• 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,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2007
• 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: 16 YR