MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Device Problem Low impedance (2285)

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

Event Date 10/09/2015

Event Type  malfunction  

Event Description

It was reported that low impedance was identified inside and outside the chest pocket during a generator replacement surgery.Generator diagnostics were performed with the test resistor, which resulted in normal impedance.The lead pins were fully inserted two different times, but the low impedance was still present.The patient was closed up, and no known lead revision surgery has occurred to date.

Event Description

Programming history was reviewed for the patient's generator and confirmed the low impedance.Low impedance was also observed during a recent clinic visit.No additional relevant information has been received to date.No surgical intervention has occurred to date.

Event Description

The patient underwent lead and generator replacement surgery.The explanting facility did not return the explanted devices to the manufacturer for analysis.No additional relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 5198143
• MDR Text Key: 30602901
• Report Number: 1644487-2015-06314
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: 11/02/2017; 04/10/2018
• Supplement Dates FDA Received: 11/27/2017; 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 53 YR