FDA Adverse Event Injury Summary report: N

STIMQ NEUROSTIMULATOR

MDR report key: 11988783 · Received June 12, 2021

Report

Report Number: 3010676138-2021-00124
Event Type: Injury
Date Received: June 12, 2021
Date of Event: February 19, 2021
Report Date: June 12, 2021
Manufacturer: STIMWAVE TECHNOLOGIES INC.
Product Code: GZF
PMA / PMN Number: K171366
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CLINICAL REPRESENTATIVE MET WITH THE PATIENT AND INSTRUCTED THE PATIENT TO RELOCATE THE ANTENNA'S POSITION. NO FURTHER ISSUES HAVE BEEN REPORTED. THE UNINTENDED STIMULATION QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, THE PATIENT UNDERGOING AN MRI, PATIENT SUFFERING A FALL SINCE THE IMPLANT PROCEDURE, AND THE PATIENT ENGAGING IN OVEREXTENDING MOVEMENTS HAVE BEEN RULED OUT AS POTENTIAL CAUSES. THE CLINICAL REPRESENTATIVE DISCLOSED THE ANTENNA'S POSITION WHILE WEARING THE DEVICE WAS CAUSING THE DISCOMFORT EXPERIENCED. THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF THE DISCOMFORT IS DUE TO WAA ANTENNA PLACEMENT (PATIENT USER ERROR).

Description of Event or Problem · 1

THE PATIENT REPORTED FEELING AN ELECTRIC-TYPE SENSATION OVER THE SKIN FROM THE ANTENNA DOWN TO THE TOES ON THE LATERAL ANTERIOR SIDE OF THE RIGHT LOWER LEG.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
885078	STIMQ NEUROSTIMULATOR	PERIPHERAL NERVE STIMULATOR	GZF	STIMWAVE TECHNOLOGIES INC.	PDBT-915-2K	00404-D

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other