STIMROUTER

Additional Manufacturer Narrative

PATIENT EXPERIENCED LOCALIZED PAIN AND DISCHARGE APPROXIMATELY 10 DAYS POST IMPLANT OF THE STIMROUTER DEVICE. THE PATIENT ALSO EXPERIENCED A LACK OF PAIN RELIEF FROM STIMULATION. THE PATIENT SENT PHOTOS TO THE SALES REP AND THE PHYSICIAN WHO PRESCRIBED KEFLEX AT A FREQUENCY OF FOUR TIMES PER DAY. AT THE PATIENTS IN PERSON FOLLOW-UP APPOINTMENT, THE PHYSICIAN RECOMMENDED AN EXPLANT DUE TO AN INFECTION AROUND THE LEAD, WHICH THE PATIENT DID NOT WANT AT THAT TIME. THE PHYSICIAN AND THE PATIENT DECIDED TO INCREASE THE INCISION SITE TO ALLOW FOR DRAINAGE AND PRESCRIBED A NEW ORAL ANTIBIOTIC TO CONTROL THE INFECTION AND SALVAGE THE IMPLANT. PHOTOS INDICATE REDNESS SKIN BREAKDOWN/OPENING, AND POSSIBLE DRAINAGE AND A LACK OF HEALING FROM THE SURGICAL WOUND. THE SKIN REACTION APPEARED TO BE MOST CONSISTENT WITH A POST-OPERATIVE INFECTION/CELLULITIS. CT SCAN COMPLETED ON (B)(6) 2026 IDENTIFIED A METALLIC FOREIGN BODY CONSISTENT WITH THE IMPLANTED DEVICE IN THE DISTAL LATERAL THIGH WITH ASSOCIATED FAT STRANDING, SUGGESTIVE OF LOCALIZED INFLAMMATION. NO ORGANIZED ABSCESS, FRACTURE, OR DESTRUCTIVE BONY LESION WAS IDENTIFIED. FOLLOW UP FROM CUSTOMER SERVICE REVEALED THAT THE INFECTION WAS CLEARED AND TREATMENT WOULD RESUME. MEDICAL ASSESSMENT OF THE REPORTED EVENT IS ONGOING. THE INVESTIGATION OF THE INVOLVED ST2-1000 STIMROUTER IMPLANTABLE LEAD AND LEAD INTRODUCER KIT, STERILE PRODUCTION LOT RECORDS IS ONGOING.

Description of Event or Problem

PATIENT EXPERIENCED LOCALIZED PAIN AND DISCHARGE APPROXIMATELY 10 DAYS POST IMPLANT OF THE STIMROUTER PNS DEVICE. THE PATIENT ALSO EXPERIENCED A LACK OF PAIN RELIEF FROM STIMULATION. THE PATIENT SENT PHOTOS TO THE SALES REP AND THE PHYSICIAN WHO PRESCRIBED KEFLEX AT A FREQUENCY OF FOUR TIMES PER DAY. AT THE PATIENTS IN PERSON FOLLOW-UP APPOINTMENT, THE PHYSICIAN RECOMMENDED AN EXPLANT DUE TO AN INFECTION AROUND THE LEAD, WHICH THE PATIENT DID NOT WANT AT THAT TIME. THE PHYSICIAN AND THE PATIENT DECIDE TO INCREASE THE INCISION SITE TO ALLOW FOR DRAINAGE AND PRESCRIBED A NEW ORAL ANTIBIOTIC TO CONTROL THE INFECTION AND SALVAGE THE IMPLANT. THE IMPLANT OF THE TALISMANN MODEL TM-1000 PNS DEVICE UTILIZED THE STIMROUTER MODEL ST2-1000 STIMROUTER IMPLANTABLE LEAD AND LEAD INTRODUCER KIT, STERILE. THIS REPORT IS FOR THE STIMROUTER MODEL ST2-1000 PNS DEVICE.