MAUDE Adverse Event Report: CYBERONICS VNS

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

Patient Problems Bruise/Contusion (1754); Pain (1994); Electric Shock (2554)

Event Date 07/21/2016

Event Type  Injury  

Event Description

A cyberonics vns implant for epilepsy malfunctioned and the device could not be shut off by the patient's magnet.This caused much pain, fear, and the patient to incur bruising.The patient, after trying to turn it off and it getting worse, had his pregnant wife drive him to the emergency room of the hospital where the device was implanted and where the neurologist he was seeing was practicing, which was over an hour away.Emergency room personnel could not shut off the device, but taped a pace maker magnet on his chest and told him he could go home.He insisted on being admitted because he lives over an hour away, the device had not yet been shut off.He told them he'd sleep in his car if he had to.They could not contact his old neurologist (she recently left that hospital, but there was no forwarding information) and he had not yet seen his new neurologist.They finally admitted him for 'observation.' the neurologist they finally had come look at him knew nothing about the device and it took considerable pleading from the patient for them to find someone who could shut it off.Further, the staff treated the patient as if he was crazy or at least not in full control of his faculties, yet they never contacted a psychiatrist.The patient was in full control of his faculties and was the one explaining the device to health care providers.It turned out that the device was not only erratic and shocking him continuously for long periods of time, it was also set too high.If they had not found a representative that sold the devices to come and shut it off, it could have been life threatening.That kind of stress and not being able to get enough sleep are triggers for the epilepsy.He can't breathe sometimes when that device goes off normally, much less in that mode, and it had to have been hard on his heart, not to mention the bruising and pain he was in.He was also scared and many of the people treating him were condescending, rude, and when the patient asked them about (b)(6) (where he doctored for years), the neurologist said she'd never heard of it and brushed it off.Have they not heard of (b)(6)? the rep for the device claimed they'd never had anything like that happen and certainly not any that caused injury or death, which i found out was not true when i checked the fda website.I don't know that the medical personnel or the manufacturer will report this, and it needs reporting.It's currently turned off and he was able to come home, but he wants it removed and they keep advising him not to remove it.If it has malfunctioned, why would you not want to at least remove it or the battery?.

• Brand Name: VNS
• Type of Device: VNS
• Manufacturer (Section D): CYBERONICS
• MDR Report Key: 5836193
• MDR Text Key: 50935564
• Report Number: MW5063745
• Device Sequence Number: 1
• Product Code: LYJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2016

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 43 YR