MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Positioning Problem (3009)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 01/17/2006

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device showed high impedance.X-rays were taken and showed that the lead pin may not be fully inserted into the generator header.The patient¿s parents elected to disabled the patient¿s device not and pursue surgery.The patient¿s seizure control did not change due to the disablement; however, it was noted that the patient may not have had any efficacy with vns prior to the event.No known surgical interventions have occurred to date.

Manufacturer Narrative

Describe event or problem, corrected data: initial report inadvertently mentioned lack of efficacy that was noted for a different patient.The lack of efficacy for the patient in this report was not reported until the date that information was received for supplemental report #01.

Event Description

Information was received that the patient's vns was disabled due to it shocking the patient and not providing benefit at the time that high impedance was identified.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 4100841
• MDR Text Key: 21494285
• Report Number: 1644487-2014-02381
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2007
• Device Model Number: 102
• Device Lot Number: 013476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2005
• 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: 10 YR