MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Failure to Interrogate (1332); Failure to Power Up (1476); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem Seizures, Grand-Mal (2168)

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that the patient';s vns generator was unable to be interrogated on two different occasions on (b)(6) 2016.The physician's office suspected that the issue was with their programming system but were unable to rule out the patient's generator as being a cause.The programming wand battery was checked and the power light did not turn on at all during troubleshooting.It is suspected that the 9 v battery might have been depleted, resulting the failure of communication.The battery was changed and the wand was confirmed to be working properly.The programming system worked properly with the demo generator but the patient's generator could not be confirmed.The patient was in a car accident recently and experienced two grand mal seizures since then.The reason for the patient's visit was to check the device function to ensure that there were no lead related issues due to the car accident.

Event Description

Patient underwent prophylactic generator replacement.The lead was not replaced and the lead impedance marked on the implant card is noted as ok.The explanted devices are usually discarded by the hospital and the explanted generator has not been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5518753
• MDR Text Key: 41182478
• Report Number: 1644487-2016-00624
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2014
• Device Model Number: 103
• Device Lot Number: 202142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2012
• 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: 43 YR