MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 7103; GENERATOR

Model Number 7103

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

Patient Problem Pain (1994)

Event Date 10/16/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced a severe adverse event of painful stimulation that was reported to be probably related to stimulation, and not related to system other or implant.Information was received regarding the patient's reported "painful stimulation".It was noted this painful stimulation was of "moderate" severity, and "probably related" to vittaria system stimulation with rationale "subject complains of pain where vagal nerve stimulator is located in neck since his defibrillator shocked this morning.It resolves when he places the magnet over his neck".It was also noted to be "possibly related" to the patient's underlying disease with pi rationale "this started immediately after his defibrillator device shocked him".It was stated that the action taken with the study treatment is "stimulation interrupted with magnet".It was noted that treatment was required "non-drug treatment", the patient has recovered, and the event is serious noted to be "disabling/incapacitating".It was also noted that there are other possible contributing factors to the serious adverse event, specifically the defibrillator shock.An exact description of the report was given as follows: "subject called with complaints of painful stimulation from vns that woke him up from sleep.Physician received phone call from cardiac device clinic that subject's defibrillator shocked at 5:30 am during a ventricular fibrillation episode, the subject was not aware of this until he received a call from the device clinic that he should seek medical attention.The subject has been unable to tolerate vns since the shock and has kept the magnet on.He has tried to remove it a few times but assesses the pain as 8.5 out 10 and wanted to leave the magnet on.His defibrillator is on the left side, the vns is on his r side and magnet is taped on his neck." it was also stated "subject seen¿vns was able to be turned back on at an acceptable threshold for the subject to tolerate." no additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 7103
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 10817906
• MDR Text Key: 215570239
• Report Number: 1644487-2020-01504
• Device Sequence Number: 1
• Product Code: MUZ
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2020

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: 01/29/2020
• Device Model Number: 7103
• Device Lot Number: 204479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2018
• 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: 59 YR