MAUDE Adverse Event Report: SYMMETRY GEN MODEL 8103; GENERATOR

Model Number 8103

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

Patient Problems Arrhythmia (1721); Bradycardia (1751)

Event Date 12/09/2020

Event Type  Injury  

Event Description

It was reported that the patient sent into asystole during implant surgery.When system diagnostics were performed, the patient heart rate dropped to asystole.Anesthetist administered atropine and the patient heart rate went back to normal.System diagnostics were performed again and patient went into asystole again.Stimulation was attempted at 0.25ma and no heart rate change was observed.It was noted that the patient had a known bradycardia and had no support from a cardiologist right now.It was stated that the bradycardia would have to get solved by medication or a pacemaker.No additional relevant information has been received to date.

Event Description

It was reported that bardycardia was observed at 1.0ma and 1.5ma.No arrhythmia was observed at 0.25ma.The relationship was reported to be causal due to vns stimulation.No additional relevant information has been received to date.

Manufacturer Narrative

A2.Age at time of event - correction - patient age was incorrectly reported in initial mdr.F10.Adverse event problem, health effect - clinical code - correction - code e060104 for "bradycardia" was not included in supplemental #1 mdr.

Event Description

The bradycardia and asystole were reported to be casual to the implant surgery as well as device stimulation.The patient discontinued the clinical trial.The patient had a full system explant performed.The explanted devices were noted to be not available for return.The explanted devices have not been received to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient had asystole occur with system diagnostics at 0.25ma.No additional relevant information has been received.

Manufacturer Narrative

B5.Describe event or problem: no heart rate change at 0.25ma reported was incorrectly included in inital mdr.

• Brand Name: SYMMETRY GEN MODEL 8103
• Type of Device: GENERATOR
• MDR Report Key: 11059794
• MDR Text Key: 223358456
• Report Number: 1644487-2020-01721
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/04/2021

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: 09/24/2021
• Device Model Number: 8103
• Device Lot Number: 205106
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/23/2020; 02/03/2021; 11/04/2021
• Supplement Dates FDA Received: 01/15/2021; 04/15/2021; 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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; Required Intervention
• Patient Age: 64 YR