MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 101; GENERATOR

Model Number 101

Device Problem Low impedance (2285)

Patient Problems Seizures (2063); Inadequate Pain Relief (2388)

Event Date 03/14/2002

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that the patient's caregiver wanted to have the patient's vns removed due to lack of efficacy.Later, the caregiver reported that the patient's seizures were worse when his vns was on.It is unknown if/when the patient's device was disabled or if the patient had efficacy, because the patient's physician that managed his vns had since retired.Programming history also indicated that there may have been low impedance, as of (b)(6) 2007.The impedance had been within normal limits from 2003 - 2007, so there was no indication that low impedance had been present the entire time the device was implanted.However, the caregiver's reports of lack of efficacy and increased seizures may have been related to low impedance.Attempts for further information were unsuccessful to date.No surgical intervention has occurred to date.

• Brand Name: PULSE GEN MODEL 101
• Type of Device: GENERATOR
• 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: 5399400
• MDR Text Key: 37731439
• Report Number: 1644487-2016-00180
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2003
• Device Model Number: 101
• Device Lot Number: 5498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2002
• 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 Outcome(s): Other
• Patient Age: 31 YR