MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Shut Off (2939)

Patient Problem Electric Shock (2554)

Event Date 07/16/2016

Event Type  malfunction  

Event Description

It was reported that a patient experienced an electric shock while working on her house and their vns settings had been adjusted before the next interrogation.The patient's parameters had reportedly changed after the electrocution.The device did not shut itself off, but the settings had decreased.The patient's physician set the parameters back to where they had previously been and no further intervention was needed.Diagnostics were performed both before and after the electric shock and were reportedly within normal limits on both occasions.The device history record for the generator was reviewed and verified that the generator passed all of the manufacturer's inspections prior to release for distribution.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 5942927
• MDR Text Key: 54880249
• Report Number: 1644487-2016-02054
• 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: Physician
• Type of Report: Initial
• Report Date: 08/18/2016

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: 02/27/2015
• Device Model Number: 102
• Device Lot Number: 202481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2013
• 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: 33 YR