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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 10/19/2016

Event Type  malfunction  

Event Description

Prior to a generator replacement surgery on the date of surgery, a company representative detected high impedance (62;10,000 ohms).The patient's generator was being replaced due to ifi-yes.When the patient's new generator was implanted, high impedance was observed again.Therefore, the patient underwent lead revision as well and the impedance issue resolved.The suspect product was received.Product analysis has not be completed to date.No additional relevant information was received to date.

Event Description

The internal data of the generator was obtained from analysis of the device, and it was identified that the last >25% change in impedance occurred on (b)(6) 2016.No additional relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the explanted lead.Two portions of the lead were returned, including the lead pin.The electrode array and a portion of the lead body were not returned.Based on the returned portions of lead analyzed, a lead fracture was not confirmed.The condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.No additional relevant information has been received 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: 6115132
• MDR Text Key: 60844852
• Report Number: 1644487-2016-02649
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2006
• Device Model Number: 302-20
• Device Lot Number: 10960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2005
• 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: 19 YR