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

Model Number 304-20

Device Problem Fracture (1260)

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

Event Date 12/06/2016

Event Type  malfunction  

Event Description

It was reported that during prophylactic generator replacement surgery the surgeons observed a fracture in the existing lead.Diagnostic testing was performed preoperatively and the result was within acceptable limits.It was noted that at the point of the fracture the lead appeared to be flattened.The surgeons did not believe that they had cut the lead during the surgery.The generator and portion of the fractured lead were then explanted and a new lead and generator were placed a few days later.The explanted products were received and are pending product analysis.No additional information has been received to date.

Event Description

Product analysis was performed on both the explanted generator and portions of the explanted lead.During the explant surgery a portion of the patient's lead was cut into three segments.Each segment was evaluated for continuity and no discontinuities were identified.There were no functional anomalies seen with the lead.However only a portion of the lead was returned, no conclusions can be drawn regarding the portion of the lead that was not returned.Setscrew marks were observed on the connector pin of the lead and provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin, thereby ensuring a good electrical connection to the lead.The generator was also evaluated and no functional anomalies were identified with the generator.The data on the generator was reviewed and it was noted that there was a change >25% in impedance on the day following the explant surgery.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• 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: 6214375
• MDR Text Key: 63611083
• Report Number: 1644487-2016-02951
• 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
• Report Date: 01/30/2017

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: 04/30/2015
• Device Model Number: 304-20
• Device Lot Number: 2981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2011
• 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: 36 YR