MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; LEAD

Model Number 302-20

Device Problem Fracture (1260)

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

Event Date 01/30/2017

Event Type  malfunction  

Event Description

It was reported (b)(6) 2017 that a vns patient was scheduled for a prophylactic replacement.High lead impedance was observed prior to the case.The new generator was connected to the lead and diagnostics were repeated.High lead impedance was still observed.The patient had a full revision, with the placement of the new lead and generator on the right side.A portion of the lead was explanted.It was noted by the patient's neurologist that high lead impedance was also observed in clinic after the patient reported some falls.The explant facility does not return the devices without a patient release per policy.Additional relevant information has not been received to-date.

• Brand Name: PULSE GEN MODEL 103
• 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: 6356440
• MDR Text Key: 68354585
• Report Number: 1644487-2017-03257
• 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: Health Professional
• Type of Report: Initial
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2005
• Device Model Number: 302-20
• Device Lot Number: 009206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2003
• 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: 56 YR