URGENT PC NEUROMODULATION SYSTEM
Received Apr 8, 2021
Report 3002647932-2021-00003 · MDR key 11636858
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Description of Event or Problem
UROPLASTY INITIALLY REPORTED ON A PATIENT WHO EXPERIENCED A SEIZURE DURING AN URGENT PC PROCEDURE. THIS REPORT IS INTENDED AS A FOLLOW-UP TO THE INITIAL REPORT TO CLARIFY THAT THE OFFICIAL DIAGNOSIS FROM THE HOSPITAL FOR THIS PATIENT WAS A VASOVAGAL SYNCOPE AND NOT A SEIZURE. VASOVAGAL SYNCOPE IS A KNOWN RISK OF THE URGENT PC PROCEDURE AND IS NOT CONSIDERED TO BE LIFE-THREATENING.
Additional Manufacturer Narrative
IT IS CURRENTLY UNCLEAR WHAT, IF ANY, RELATION THE USE OF THE URGENT PC DEVICE HAD IN THE CAUSE OF THE SEIZURE FOR THIS PATIENT. UROPLASTY, LLC IS ACTIVELY FOLLOWING UP WITH THE REPORTER AND WILL PROVIDE ADDITIONAL INFORMATION TO FDA AS IT BECOMES AVAILABLE.
Description of Event or Problem
UPON UNDERGOING THEIR FIRST TREATMENT WITH THE URGENT PC NEUROMODULATION SYSTEM, A PATIENT BECAME NAUSEOUS AND THEN EXPERIENCED A SEIZURE SHORTLY AFTER THE START OF THE PROCEDURE. THE PATIENT WAS SENT BY AMBULANCE TO THE ER.