FDA Adverse Event Injury Summary report: N

FREEDOM NEUROSTIMULATOR

MDR report key: 11985419 · Received June 11, 2021

Report

Report Number: 3010676138-2021-00120
Event Type: Injury
Date Received: June 11, 2021
Date of Event: May 12, 2021
Report Date: June 11, 2021
Manufacturer: STIMWAVE TECHNOLOGIES INC.
Product Code: GZB
PMA / PMN Number: K171366
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE UNINTENDED STIMULATION QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, THE PATIENT EXPERIENCING A FALL, ENGAGING IN STRENUOUS ACTIVITIES, PATIENT OVEREXTENDED OR OVEREXERTED, CAUSING THE STIMULATOR TO MOVE, CHANGING THE WAA PARAMETERS INTENTIONALLY/UNINTENTIONALLY, AND THE WAA GOING THROUGH AN ELECTRICAL DISCHARGE OR BEEN AROUND OTHER ELECTRO-MAGNETIC SOURCES HAVE BEEN RULED OUT AS POTENTIAL CAUSES. THE IMPLANTING CLINICIAN STATED THE CAUSE OF THE SHOCK WAS MIGRATION. HOWEVER, X-RAYS HAVE NOT BEEN TAKEN TO CONFIRM MIGRATION. THE ELECTRICAL SENSATION COULD HAVE BEEN CAUSED BY HIGH PROGRAMMING PARAMETERS AND/OR STIMULATOR PLACEMENT TOO NEAR TO THE NERVE. THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF THE OVERSTIMULATION IS UNKNOWN/NO FAULT FOUND.

Description of Event or Problem · 1

THE PATIENT REPORTED FEELING A SHOCK ON TWO DIFFERENT OCCASIONS. THE PATIENT IS REQUESTING THE DEVICE BE EXPLANTED. HOWEVER, THE DEVICE HAS NOT BEEN EXPLANTED AS OF YET AND HE PATIENT WAS INSTRUCTED TO KEEP THE THERAPY OFF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
877451	FREEDOM NEUROSTIMULATOR	SPINAL CORD NERVE STIMULATOR	GZB	STIMWAVE TECHNOLOGIES INC.	FR8A-RVC-A0, FR8A-SPR-B0	SWO190815, SWO197090

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other