MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Undesired Nerve Stimulation (1980); Loss of consciousness (2418)

Event Date 08/25/2015

Event Type  Injury  

Event Description

It was reported that the vns patient experienced bradycardia with a possible 10 second asystole event that occurred when performing system diagnostics on (b)(6) 2015.Radial and brachial pules were nonpalpable and heart rate was non-audible during this 10 second period.The patient suddenly slumped in his chair and was unresponsive.The physician attributed the asystole event to vns stimulation.The patient's heartbeat prior to the suspected asystole event was 56 bpm.The patient did not display any symptoms and did not experience any traumatic events leading up to the event.No changes to device settings or medications preceded the onset of the event.Before performing system diagnostics, x-rays were taken and were reported by the physician to be unremarkable.The device was subsequently disabled.The patient did not have a prior history of cardiac events.The patient underwent a 14-day holter monitoring period on (b)(6) 2013 which was reported by the physician to be unremarkable.The patient was admitted to the hospital and evaluated by the emergency department to preclude a serious injury to the patient.The event has not reoccurred and the patient has been doing well following the event.System diagnostic results showed lead impedance within normal limits.It was noted that the patient had been experiencing painful stimulation for 12-24 hours prior to the asystole event.

Event Description

It was later reported that the device was explanted at an unknown date.The physician later responded that the reason for the explant was due to sharp pain which improved initially with adjustment in settings.Then the pain recurred and patient was brought to clinic after chest x-ray for urgent appointment.Vns diagnostic mode was run in clinic and he became dusky and slumped in his chair.Radial pulses could not be appreciated for 5-10 seconds and he was sent to er after vns turned off.The date of the explant and surgery details were provided.Both lead and generator were explanted with the electrodes left attached.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 5092187
• MDR Text Key: 26352004
• Report Number: 1644487-2015-05860
• 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
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2013
• Device Model Number: 103
• Device Lot Number: 201860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2011
• 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): Hospitalization; Life Threatening; Hospitalization; Life Threatening; Required Intervention; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male