MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Arrhythmia (1721); Tinnitus (2103); Hypoesthesia (2352)

Event Date 03/01/2018

Event Type  Injury  

Event Description

It was reported by the anesthesiologist that patient was in clinic being induced after her baby had passed away in utero, which was not attributed to the vns.The patient received an epidural and it was reported that she had low blood pressure from the epidural and experienced syncope with vns stimulation.The physician did feel these syncope events are associated with the combination of the vns and epidural as it was stated that the clinical effects of an epidural on a patient's body have the potential for a drop in blood pressure.It was stated that the first syncope event occurred and passed.By the time the second event occurred, the patient knew it was related to the vns as she was familiar with the sensation of stimulation and the effects of stimulation.There were no lasting effects for the patient and the physician was hopeful for the patient to become pregnant again.No additional relevant information has been received to date.

Event Description

An article was received by the manufacturer regarding the reported event.Per the article, the patient was diagnosed with polyhydramnios.All initial levels at time of induction were unremarkable.Patient-controlled epidural analgesia (pcea) was started.No abnormalities were noted in the patient's blood pressures at two minute intervals for the first twenty minutes after placement of the epidural.Approximately 40 minutes after the initial dose, the patient experienced a loss of consciousness during placement of an intra-cervical foley bulb.The patient regained consciousness within a few seconds with no disorientation and described tinnitus immediately prior to the loss of consciousness.The patient's blood pressure was unchanged from the baseline.The initial diagnosis was that the vasovagal syncope was related to the foley bulb placement as there was no motor block or nystagmus.The patient experienced a loss of consciousness five minutes later with no obvious causative event.When the patient regained consciousness, she stated that the syncope immediately followed vns stimulation, which she recognized due to voice alterations and a "tickling pressure sensation." ephedrine was administered and continuous ecg and pulse oximetry monitoring was started.The next vns stimulation was without event.It was then decided by the medical professionals and patient to disable the vns via magnet disablement.The epidural was restarted and the labor/delivery was completed with no further episodes of syncope.The patient was not received any medications beyond the epidural infusion which might have predisposed her to the syncope.There was no clinical/laboratory evidence to suggest preeclampsia, seizure, placental abruption, or sepsis.Local anesthetic system toxicity was among the initial differential diagnoses for the syncope and the anesthetic infusion was temporarily discontinued with resuscitative supplies kept in close proximity.It was stated that during an epidural block, "a reduction in venous return can increase vagal activity, secondary to decreased right atrial filling, leading to a reduced signal output from intrinsic chronotropic stretch receptors".It was suspected that this change combined with vns stimulation led to a reversible arrhythmia and that a further increase in vagal tone from the foley bulb placement contributed to the first syncope.

• Brand Name: PULSE GEN MODEL 106
• 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: 8149367
• MDR Text Key: 129877170
• Report Number: 1644487-2018-02261
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 03/12/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2019
• Device Model Number: 106
• Device Lot Number: 204205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 02/16/2019
• Supplement Dates FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2017
• 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 Outcome(s): Other
• Patient Age: 34 YR