STIMROUTER
Received Jul 23, 2025
Report MW5173160 · MDR key 22579014
Device
Generic name
Stimulator, Peripheral Nerve, Implanted (pain Relief)
Manufacturer
Bioventus Llc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Rash
- Skin Erosion
- Skin Infection
- Skin Inflammation/ Irritation
- Rash
- Skin Erosion
- Skin Infection
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
ON 2025-JUL-10: INFORMATION WAS RECEIVED FROM A PATIENT REPRESENTATIVE. PT REP DID NOT HAVE THE SERIAL NUMBER OR ANY INFO ON THE DEVICE. PT IS NOT REGISTERED. DOB (B)(6) 1983. PT REP STATED PT HAS A DEVICE BUT PT REP DID NOT KNOW WHAT DEVICE THEY HAD. PT REP SAID, "I KNOW IT IS A (B)(6) DEVICE". THEN PT SAID THEY THOUGHT IT WAS (B)(6) BUT WAS NOT SURE. PT REP SAID THE DEVICE IS IMPLANTED PT HAD TO PUT A PATCH ON WHEN THEY NEEDED TO ACTIVATE IT. THE REASON FOR CALL WAS FOR OVER A YEAR PATIENT STARTED GETTING A REALLY BAD RASH FROM THE DEVICE. PATIENT WAS TRYING TO TOLERATE IT BUT NOW PATIENT COULD NOT DO IT ANYMORE. PATIENT'S SKIN WAS GETTING EATEN AWAY ALMOST. PATIENT'S MANAGING HCP IS DR. (B)(6) BUT PT REP WAS NOT SURE. PT REP CALLED TO GET INFORMATION ON IMPLANTING THE INCEPTIVE DEVICE. TRANSFERRED TO CAMPAIGN SOLUTIONS. PT REP ALSO ASKED FOR HCP LISTINGS. PROVIDED LOCATOR WEBSITE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).