MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problem Fracture (1260)

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

Event Date 07/26/2018

Event Type  malfunction  

Event Description

During a generator replacement surgery, the generator was replaced and diagnostics on the new generator attached to the lead showed high impedance.The impedance was measured 5 times, lead pin insertion was check, the header was rinsed with solution, and lead pin was cleaned.However the device still showed high impedance.Visually the surgeon examined an insulation defect right where the stiff pin part of the lead ends but felt sure the wire itself still intact.No trauma has been reported by the caregiver but there are injuries reported in the past, caused by accident.X-rays were taken.No known surgical interventions have occurred to date to replace the lead.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7798706
• MDR Text Key: 117700120
• Report Number: 1644487-2018-01445
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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
• Report Date: 08/20/2018

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
• Device Expiration Date: 03/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200754
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2008
• 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: 31 YR