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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 04/26/2016
Event Type  Injury  
Event Description

It was reported that a vns patient was implanted on (b)(6) 2016 and there were no issues during the implantation; however, while running a system diagnostics (1ma output current, 500c pulse width and 20hz signal frequency), the patient developed an irregular heart rhythm that went into a bundle branch block. This spontaneously resolved within a few minutes. After a while, a second system diagnostics test was performed (while the patient was still under anesthetic) and the same event occurred. Once this was resolved, they programmed the normal mode to 0. 25ma output current, 30hz signal frequency, 250 sec pulse width, 30sec on time and 5min off time. Then an output current of 0. 5ma went fine as well. An output current of 0. 75ma caused a slight arrhythmia which was resolved. At 1ma output current, the patient had the same reaction of an irregular arrhythmia followed by a bundle branch block, which spontaneously resolved. It was reported that the patient has no cardiac history, and the cardiac exam before surgery (in pre-operative assessment) was normal. Vns has been left switched off. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. Further information from the nurse indicated that the patient's device has been switched on and turned up to 1. 25ma output current with no repetition of the previous events, on (b)(6) 2016. The patient is currently under cardiac investigation and vns was switched off again. It was reported that the patient was hemodynamically stable during the arrhythmia. An ecg was performed and reviewed by a cardiologist who noted the transient 2:1 av block. His baseline heart rate was 60 - 70bpm. Following stimulation there was a transient 2:1 block followed by a sinus tachycardia with left bundle branch block (hr 95). At no time did the patient go into atrial fibrillation. This lasted 5-10min with no hemodynamic compromise. He reverted back to a normal qrs complex; when the stimulation was tested again there was a transient bradycardia and then he became more tachycardic (hr 90) then sinus rhythm again with a bundle-branch block. This settled again after 5 minutes. It was reported that at emergence the nurse reversed residual neuromuscular blockade with neostigmine and glycopyrrolate which put his heart rate up to 110 bpm (side-effect of the glycopyrrolate) and he moved from a narrow complex to a bundle branch block. The patient was reviewed in recovery by a consultant cardiologist who feels there are 2 things going on here: firstly, he has rate-related bundle branch block with appears to occur above a heart rate of 80. In recovery it was very apparent to see when his heart rate dropped below 80 his qrs complexes were normal. When it rose above 80 he had a broad-complex. Secondly, on the periods immediately following stimulation, he appears to go into a very short-lived (5 seconds or so) 2:1 av block. It was reported that the anesthetics used and their dosage are: induction (intravenous propofol (200mg), fentanyl (200mcg) and atracurium (45mg)); maintenance (inhalational desflurane (end-tidal desflurane 6. 2), incremental fentanyl for analgesia (50mcgs total), intravenous paracetamol (1g)). No further information was provided to date.

 
Event Description

Further information was received from the nurse indicating that the patient spent 10 days in the hospital undergoing tests by the cardiologist. According to the nurse, the patient indicated to her that his results were normal but the cardiologist suggested to not switch vns on. It was reported that the nurse has finally performed another diagnostic test (which set off the arrhythmia in theatre) and nothing happened. She decided to switch the device on and increased the output current to 1. 25ma, and still no arrhythmia or av block as the day before.

 
Manufacturer Narrative

(b)(4).

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5659529
Report Number1644487-2016-01039
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation Nurse
Type of Report Followup
Report Date 04/26/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date01/31/2018
Device MODEL Number106
Device LOT Number4707
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/25/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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