MAUDE Adverse Event Report: CYBERONICS / LIVANOVA USA, INC. DBS STIMULATOR VAGUS NERVE STIMULATOR (VNS) SYSTEM; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number 1000

Device Problem Unintended Electrical Shock (4018)

Patient Problems Feeding Problem (1850); Paralysis (1997); Electric Shock (2554); Weight Changes (2607); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2012

Event Type  Injury  

Event Description

Reporter called to report that she was electrocuted by her stimulator by cyberonics and was rushed to the hospital.The cyberonics representative told her that the voltage was low and if it was set at a higher rate that it would not hurt so much.Upon further assessement, she was told by her neurosurgeon that her left vocal cord was paralyzed, she has psychogenic shock and that nothing was wrong with the device.In 2014 that device was removed.In (b)(6) 2020 reporter had a new stimulator implanted and has been unable to eat.Weight at implant was (b)(6) lbs and now it's (b)(6).Reporter states that her doctor told her it was due to stress.She has been unable to retrieve her medical information "it has been erased.".

• Brand Name: DBS STIMULATOR VAGUS NERVE STIMULATOR (VNS) SYSTEM
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS / LIVANOVA USA, INC.
• MDR Report Key: 11495949
• MDR Text Key: 240451074
• Report Number: MW5100017
• Device Sequence Number: 2
• Product Code: LYJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/15/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 38 YR
• Patient Weight: 81