eCoin Device Kit 1011-2447Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00860007896903), received between Dec 13, 2022 and Jun 26, 2026 — classified as 1 death, 25 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• DeathJun 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2024, AND THE DEVICE WAS ACTIVATED ON (B)(6) 2024, WITH AN AMPLITUDE SETTING OF 8 MA. ON (B)(6) 2026, THE PATIENT PASSED AWAY FROM UPPER RESPIRATORY DISEASE AND PNEUMONIA. FURTHER INFORMATION WAS RECEIVED STATING THAT THE PATIENT EXPERIENCED SEVERAL INSTANCES OF PNEUMONIA REQUIRING HOSPITALIZATION PRIOR TO THEIR PASSING FROM (B)(6) 2025 TO (B)(6) 2025 AND (B)(6) 2025 TO (B)(6) 2025.

  Patient problems: Pneumonia; Unspecified Respiratory Problem

  MAUDE report 25638589 ↗
• InjuryJun 9, 2026Use of Device Problem

  THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2025 AND THE DEVICE WAS ACTIVATED ON (B)(6) 2025 WITH AN AMPLITUDE SETTING OF 4 MA. THE DEVICE WAS REPROGRAMMED ON (B)(6) 2025 WITH AN AMPLITUDE SETTING OF 5 MA. ON (B)(6) 2026, THE PATIENT WENT IN FOR AN MRI SCAN DUE TO EXPERIENCING SOME SEVERE LOWER BACK PAIN. THE PATIENT WAS CLEARED FOR THE MRI AND THE GUIDELINES FOR HAVING AN MRI WITH THE ECOIN DEVICE WERE REVIEWED. HOWEVER, THE MRI TECHNICIANS TAPED THE PATIENT MAGNET AROUND THE PATIENT'S LEG OVER THE ECOIN DEVICE IN ORDER TO "AVOID STIMULATION DURING THE SCAN." THE PATIENT WAS PUT INTO THE MRI AND THE SCAN BEGAN. AS THE SCAN BEGAN, THE PATIENT MAGNET "SHOT OFF" OF THE PATIENT'S LEG AND THE PATIENT EXPERIENCED A BURNING SENSATION THROUGH THEIR ANKLE AND FOOT. THE MRI WAS IMMEDIATELY ABORTED. AS OF ON (B)(6) 2026, THE DEVICE REMAINS IMPLANTED, THE PATIENT HAS NOT REPORTED ANY ADDITIONAL PROBLEMS AND STATED THEIR ECOIN DEVICE IS RUNNING EVERY FOUR DAYS AS IT PREVIOUSLY WAS. THE PATIENT WILL BE EVALUATED AGAIN BY THE IMPLANTING PHYSICIAN IN SIX WEEKS FROM THEIR LAST VISIT. NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Burning Sensation; Pain

  MAUDE report 25451492 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2025 AND THE DEVICE WAS ACTIVATED ON (B)(6) 2025 WITH AN AMPLITUDE SETTING OF 2 MA. ADDITIONALLY, THE DEVICE WAS REPROGRAMMED ON (B)(6) 2026 WITH AN AMPLITUDE SETTING OF 4 MA. ON (B)(6) 2026, THE PATIENT REPORTED THE ECOIN DEVICE WAS CAUSING PERIODIC PAIN AT THE BOTTOM OF THEIR INCISION NEAR THE ECOIN DEVICE WHICH PROHIBITED THEM FROM SOME OF THEIR DAILY ACTIVITIES SUCH AS WALKING/EXERCISING. THE PAIN WAS NOT ATTRIBUTED TO DEVICE STIMULATION. THE PATIENT DETAILED THE PAIN BEGAN ONCE THE DEVICE WAS IMPLANTED AND ALTHOUGH THE INCISION WAS HEALED, IT WAS STILL VERY BOTHERSOME AND WAS DESCRIBED AS FEELING "ELECTRICAL OR SHARP." ADDITIONALLY, THE PATIENT REPORTED THEIR URINARY SYMPTOMS WERE SO SEVERE, THEY HAD TO TAKE OVERACTIVE BLADDER (OAB) MEDICATION. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026 DUE TO PATIENT EXPERIENCING PAIN. NO FURTHER INFORMATION IS AVALIABLE AT THIS TIME AND NEEDS FURTHER RESOLUTION.

  Patient problems: Pain

  MAUDE report 25355437 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT REPORTED MILD REDNESS AT THE INCISION SITE AND ANTIBIOTICS WERE PRESCRIBED. THE REDNESS RESOLVED BY (B)(6) 2024 AND THERE WAS NO LASTING IMPAIRMENT TO WOUND HEALING OR DELAYS TO ACTIVATION WHICH OCCURRED ON (B)(6) 2024.

  Patient problems: Erythema

  MAUDE report 24918586 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6), 2024 AND THE DEVICE WAS ACTIVATED ON (B)(6), 2024 WITH AN AMPLITUDE SETTING OF 8 MA. ALTHOUGH THE PATIENT WAS RESPONDING POSITIVELY TO ECOIN THERAPY, THE PATIENT STEPPED ON A PIECE OF ICE AND DEVELOPED A TOE WOUND IN(B)(6) 2026 THAT REQUIRED MEDICAL CARE FROM A PODIATRIST AS WELL AS A WOUND CARE CLINIC. AFTER RECEIVING MEDICAL CARE, THE PATIENT'S WOUND TURNED INTO CELLULITIS AND AN INFECTION OF THEIR FOOT AND LEG. THE PATIENT WAS ALSO SEEN BY INFECTIOUS DISEASE WHO TREATED THE CELLULITIS AND PRESCRIBED ORAL ANTIBIOTICS. SUBSEQUENTLY, THE SCAR FROM THE ECOIN IMPLANT OPENED AND BECAME A SUPERFICIAL WOUND. THE PATIENT WAS HOSPITALIZED DUE TO RIGHT LEG CELLULITIS ON (B)(6), 2026 AND I.V. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT WAS DISCHARGED ON (B)(6), 2026 AND ADDITIONAL ANTIBIOTICS WERE PRESCRIBED TO TAKE AT HOME. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6), 2026 AS THE PATIENT HAD UNDERGONE TREATMENT FOR MANY WEEKS WITHOUT SIGNIFICANT IMPROVEMENT. APPROXIMATELY ONE WEEK AFTER THE EXPLANT, A WOUND VACUUM-ASSISTED CLOSURE (VAC) WAS PERFORMED ON THE INCISION AREA CREATED BY THE EXPLANT. AS OF (B)(6), 2026, THE INFECTION AND C

  Patient problems: Cellulitis; Skin Infection; Wound Dehiscence

  MAUDE report 24841184 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6), 2026 AND THE DEVICE WAS ACTIVATED ON (B)(6) 2026 WITH AN AMPLITUDE SETTING OF 3 MA. ON MARCH 05, 2026, TERRITORY MANAGER, (B)(6), RECEIVED A PHONE CALL FROM THE PATIENT REGARDING AN INFECTION AT THE INCISION SITE AND ANTIBIOTICS WERE PRESCRIBED BY THE IMPLANTING PHYSICIAN. THE PATIENT DESCRIBED THE INFECTION AS AN ALLERGY TO THE SUTURING. HOWEVER, THIS WAS NOT CONFIRMED BY MEDICAL PROFESSIONALS. CULTURES OF THE WOUND WERE OBTAINED, AND THE RESULTS CAME BACK NEGATIVE, INDICATING THAT NO INFECTION WAS PRESENT. ADDITIONALLY, APPROXIMATELY ONE WEEK BEFORE THE PHONE CALL, THE PATIENT REPORTEDLY EXPERIENCED SHOOTING PAIN IN THE BOTTOM OF THEIR FOOT AND UP THEIR LEG. THE PATIENT DID NOT REPORT ANY PAIN WHEN THE DEVICE WAS INITIALLY ACTIVATED ALTHOUGH THEY WERE VERY SENSITIVE TO THE STIMULATION. ON MARCH 06, 2026, THE TERRITORY MANAGER MET WITH THE PATIENT AND TURNED THE DEVICE OFF BY PLACING IT IN SHELF MODE. ADDITIONALLY, THE PATIENT SAW A NURSE AND RECEIVED ADVICE ON THEIR WOUND. ON MARCH 11, 2026, THE PATIENT REPORTED THEIR ECOIN DEVICE WENT OFF AT 12:30PM DESPITE THE DEVICE BEING PUT IN SHELF MODE ON MARCH 06, 2026. THE PATIEN

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 24772142 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  THE CLINICAL STUDY PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2025, WITH NO ISSUES REPORTED. THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS FROM ON (B)(6) 2025. ON (B)(6) 2025, A WOUND INFECTION WAS REPORTED AT THE INCISION SITE. ADDITIONAL ANTIBIOTICS WERE PRESCRIBED FROM ON (B)(6) 2025 AND THE INFECTION RESOLVED. THE DEVICE WAS ACTIVATED ON (B)(6) 2025 WITH AN AMPLITUDE SETTING OF 4 MA.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24539267 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2025. ON (B)(6) 2025, THE WOUND WAS CLEARED FOR ACTIVATION WITH NO SIGNS OF INFECTION AT THE TIME AND THE DEVICE WAS ACTIVATED WITH AN AMPLITUDE SETTING OF 6MA. ON (B)(6) 2026, THE TERRITORY MANAGER BECAME AWARE THAT THE PATIENT WAS EXPERIENCING AN INFECTION THAT WAS SLIGHTLY OOZING FROM THE ECOIN INCISION SITE. ADDITIONALLY, THE DEVICE POCKET WAS SLIGHTLY SWOLLEN AND RED. ANTIBIOTICS WERE PRESCRIBED AND THE AREA WAS TOPICALLY CLEANED. AS OF (B)(6) 2026, THE INFECTION HAS CLEARED. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Fluid Discharge; Post Operative Wound Infection; Swelling/ Edema

  MAUDE report 24306487 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2024 AND THE DEVICE WAS ACTIVATED ON (B)(6) 2024 WITH AN AMPLITUDE SETTING OF 2 MA. THE EXECUTIVE TERRITORY MANAGER MET WITH THE PATIENT ON (B)(6) 2025 TO TURN OFF THE DEVICE DUE TO THE PATIENT FEELING SOME DISCOMFORT. THE PATIENT DID NOT EXPERIENCE ANY DISCOMFORT WITH STIMULATION. AN ULTRASOUND WAS PERFORMED WHICH SHOWED INDURATION AND POSSIBLE CELLULITIS OF THE AREA. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 04, 2025. THE PATIENT WAS EXPERIENCING PAIN AROUND THE SITE OF THE ECOIN DEVICE. ANTIBIOTICS WERE PRESCRIBED. HOWEVER, IT DID NOT RESOLVE. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Cellulitis; Discomfort

  MAUDE report 23578011 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2025. HOWEVER, THE DEVICE WAS NEVER ACTIVATED AS THE PATIENT MISSED THEIR ACTIVATION APPOINTMENT. ON (B)(6) 2025, THE PATIENT REPORTED THEIR INCISION SITE WAS NOT HEALING AND THEY HAD BEEN SEEING WOUND CARE AT THEIR PRIMARY CARE. THE IMPLANTING CLINICIAN AND TERRITORY MANAGER WERE NOT MADE AWARE OF THE DELAYED WOUND HEALING UNTIL (B)(6) 2025. THE PATIENT IS SEEING WOUND CARE FOR DEBRIDEMENT AND WILL FOLLOW-UP WITH UROLOGY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Impaired Healing

  MAUDE report 22810063 ↗
• InjuryJul 24, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED IMPAIRED WOUND HEALING AT THE INCISION SITE AS WELL AS EXPOSURE OF THE ECOIN DEVICE. THE WOUND WAS TREATED, SEVERAL ROUNDS OF ANTIBIOTICS WERE PRESCRIBED, AND THE PATIENT WAS REFERRED TO WOUND CARE. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025, THE WOUND WAS IRRIGATED, AND SUTURES WERE PLACED. THE PATIENT ATTENDED A POST-OPERATIVE APPOINTMENT AFTER THE EXPLANT PROCEDURE WHERE THE SUTURES WERE REMOVED AND IT WAS NOTED THE WOUND WAS HEALING WELL.

  Patient problems: Impaired Healing

  MAUDE report 22591432 ↗
• InjuryApr 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  79 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, IMPLANT HEALING CHECK OCCURRED AND NO ISSUES WERE NOTED. ON (B)(6) 2024, PATIENT WAS SEEN FOR ACTIVATION AND NO ISSUES WERE NOTED. APPROXIMATELY 6 MONTHS POST IMPLANTATION ON (B)(6) 2025, PATIENT REPORTED CONCERN ABOUT IMPLANT SITE. ON (B)(6) 2025, PATIENT WAS SEEN BY PHYSICIAN AND DIAGNOSED WITH SKIN CELLULITIS - BLANCHING ERYTHEMA SURROUNDING IMPLANT AREA. PATIENT WAS PRESCRIBED ANTIBIOTICS (CEPHALEXIN, 500 MG, TID). ON (B)(6) 2025, PATIENT REPORTED THAT ANTIBIOTICS DID NOT PROVIDE RELIEF. SUBJECT REPORTED THE IMPLANT SITE HAD GOTTEN "HOTTER" IN ADDITION TO STOMACH PAIN (BEGAN ON (B)(6) 2025) AND A CANKER SORE (BEGAN (B)(6) 2025). ON (B)(6) 2025, THIS WAS MARKED RESOLVED AND PATIENT WAS EXPLANTED AS ANTIBIOTICS FAILED TO RESOLVE ISSUE. ON (B)(6) 2025, NO ABNORMALITIES WERE NOTED AT THE HEALING EXPLANT CHECK. AS OF (B)(6) 2025, CULTURES WERE NEGATIVE FOR INFECTION. THE SITE MAINTAINS THE INITIAL DIAGNOSIS OF SKIN CELLULITIS.

  Patient problems: Post Operative Wound Infection; Skin Infection

  MAUDE report 21830506 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  77-YEAR-OLD FEMALE IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024 PATIENT REPORTED "SEVERE SWELLING". PATIENT WAS REFERRED TO URGENT CARE BY IMPLANTING PHYSICIAN AND GIVEN ANTIBIOTICS. ON (B)(6) 2024 IT WAS REPORTED THAT "EDEMA IS PRESENT BUT LOOKS SIGNIFICANTLY IMPROVED AS EVIDENCED BY THE WRINKLES. THE LEG DOES NOT APPEAR TO BE CELLULITIC, BUT DOES SHOW SOME INFLAMMATION, WHICH IS TO BE EXPECTED. AS OF (B)(6) 2024, PATIENT RECEIVED ANTIBIOTICS AND RECOVERED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20848123 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  61 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024 PATIENT REPORTED DISCHARGE COMING OUT AT THE BOTTOM OF INCISION. PATIENT STATED IT DOESN'T HURT JUST A LITTLE SWELLING. THE PATIENT WAS TREATED WITH BACTRIM AND RECOVERED AS OF (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19933680 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  83 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2024. AT ACTIVATION APPOINTMENT ON (B)(6) 2024 PRESENTED WITH AN INFECTION AT THE INCISION SITE. ACTIVATION WAS DELAYED DUE TO INFECTION AND PATIENT WAS REFERRED TO A WOUND CARE CLINIC. PREVIOUSLY, AT 2-WEEK HEALING CHECK, PATIENT HAD "SOME REDNESS" AND WAS PRESCRIBED ANTIBIOTICS. VTC WAS NOT AWARE UNTIL 04/25/2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19378181 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  81 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2023 PRESENTED WITH A POSSIBLE INFECTION ON (B)(6) 2023. PATIENT HAD A SMALL SUPERFICIAL DEHISCENCE. PATIENT'S WOUND WAS DEBRIDED AND PRESCRIBED AN ANTIBIOTIC. PRIOR TO THE REPORT, THE PATIENT WAS SEEN ON (B)(6) 2023 FOR ACTIVATION. AT THAT TIME, THERE WERE NO SIGNS OF AN INFECTION AND THE ACTIVATION WAS COMPLETED WITH NO RELATED ISSUES NOTED. UPDATE PROVIDED ON (B)(6) 2023 COMMUNICATED THAT THE PATIENT IS "HEALING VERY WELL". PHYSICIAN AND PATIENT ARE HAPPY WITH THE PROGRESS. PATIENT WAS SWITCHED FROM WEEKLY FOLLOW-UPS TO A MONTHLY CHECK IN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18500235 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  78 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2023. PATIENT CAME IN FOR AN UNSCHEDULED VISIT ON (B)(6) 2023 WITH "MILD DISCHARGE, REDNESS AND PAIN AT UPPER ASPECT OF INCISION". PATIENT WAS PRESCRIBED AN ORAL ANTIBIOTIC REGIMEN. PATIENT "HAS RECOVERED AS OF (B)(6) 2023".

  Patient problems: Post Operative Wound Infection

  MAUDE report 18341450 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IMPLANTED ON (B)(6) 2023. PATIENT AT 2-WEEK HEALING CHECK PRESENTED ON (B)(6) 2023 WITH SIGNS OF AN INFECTION "REDNESS AT IMPLANT SITE". PATIENT WAS PRESCRIBED ANTIBIOTICS. ON (B)(6) 2023, IT WAS REPORTED "THAT THE PATIENT WAS RECOVERED".

  Patient problems: Post Operative Wound Infection

  MAUDE report 18341447 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  70 YEAR FEMALE IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, PATIENT REPORTED WOUND AND SURROUNDING AREA IS PAINFUL. PATIENT WAS OUT OF STATE FOR 3 WEEKS AND UNABLE TO SEE PHYSICIAN. PATIENT WAS ADVISED TO GO TO ER BY IMPLANTING PHYSICIAN AND PRESCRIBED ANTIBIOTICS. PATIENT WAS ACTIVATED ON (B)(6) 2023 AND "INFECTION WAS CLEARED".

  Patient problems: Post Operative Wound Infection

  MAUDE report 18341441 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  73 YEAR OLD FEMALE IMPLANTED ON 10/17/23. AT THEIR ACTIVATION APPOINTMENT ON (B)(6) 2023 PRESENTED WITH AN INFECTION AT THE INCISION SITE. PATIENT REPORTED DISCHARGE AND REDNESS AT THE INCISION WHICH BEGAN ON (B)(6) 2023. PATIENT WAS STARTED ON 10 DAY ORAL ANTIBIOTIC REGIMEN ON (B)(6) 2023. AS OF (B)(6) 23, PATIENT IS SCHEDULED FOR ACTIVATION ON (B)(6) 23.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18332568 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  73 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2023. AT THEIR 2 WEEK HEALING CHECK, THE IMPLANTING PHYSICIAN NOTED A POTENTIAL INFECTION AND PATIENT WAS PRECRIBED A ROUND OF ANTIBIOTICS (I.E. CLYNDAMIACIN). ON (B)(6) 2023, THE PATIENT WAS SEEN FOR THEIR ACTIVATION APPOINTMENT. THE PATIENT PRESENTED WITH CONTINUED SIGNS OF INFECTION (I.E. AREA WAS SLIGHTLY RED, AND SKIN AROUND INCISION WAS HARD). ON (B)(6) 2023, PATIENT WAS CLEARED FOR ACTIVATION BY THE PHYSICIAN. ON (B)(6) 2023, AN UPDATE WAS RECEIVED THAT THE PATIENT IS HEALED AND THE INCISION CLEARED BY THE PHYSICIAN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17603891 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  68 YEAR OLD FEMALE WAS IMPLANTED ON (B)(6) 2023. THEY WERE SEEN AT THEIR 4 WEEK ACTIVATION APPOINTMENT ON (B)(6) 2023. THERE WERE NO ISSES NOTED RELATED TO HEALING OF THE INCISION AND THEY WERE CLEARED BY THE IMPLANTING PHYSICIAN FOR ACTIVATION. ON (B)(6) 2023, THE PATIENT CALLED INTO THE PHYSICIAN'S OFFICES TO REPORT OBSERVED SIGNS OF AN INFECTION (I.E. REDNESS AND PUSS) AND INCLUDES A PICTURE OF THE SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICIS (AUGMENTIN). THE IMPLANTING PHYSICIAN NOTIFIED VTC SALES PERSONNEL AT THIS TIME. UPDATES FOR THE PATIENT WERE GIVEN TO VTC ON (B)(6) 2023 THAT THE INCISION SITE AND INFECTION WERE "LOOKING MUCH BETTER". UPDATE ON (B)(6) 2023, IMPLANTING PHYSICIAN COMMUNICATED THAT THE INCISION HAS "HEALED WELL" AND "HAS NO REDNESS".

  Patient problems: Post Operative Wound Infection

  MAUDE report 17487994 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  76 YEAR OLD FEMALE IMPLANTED ON (B)(6) 2023. THEY WERE SEEN AT THEIR 4 WEEK ACTIVATION APPOINTMENT WITH NO ISSUES RELATED TO HEALING OR THE INFECTION. ON (B)(6) 2023, THEY WERE SEEN BY THE IMPLANTING PHYSICIAN'S PA. AT THIS APPOINTMENT, AN INFECTION OF THE INCISION SITE WAS NOTED BY THE PA. THE PATIENT WAS PRESCRIBED ANTIBIOTICS (I.E. IM ROCEPHIN, CEFTIN, AND FLAGYL). ON (B)(6) 2023, PATIENT RETURNED TO THE OFFICE FOR A FOLLOW-UP APPOINTMENT AND THE WOUND WAS HEALED. ON (B)(6) 2023, AT A RE-PROGRAMMING APPOINTMENT, VTC SALES PERSONNEL WAS INFORMED OF THE INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17430800 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  39 YEAR OLD FEMALE WAS IMPLANTED ON (B)(6) 2023. THEY WERE SEEN AT THEIR 2 WEEK WOUND HEALING CHECK ON (B)(6) 2023. THE PATIENT PRESENTED WITH AN INCISION SITE THAT WAS HARD TO TOUCH, PINK AND ITCHY. THE PHYSICIAN ASSISTANT DETERMINED THE SITE TO NOT BE INFECTED. ON (B)(6) 2023, THE PATIENT CALLED THE AFTER HOURS HOTLINE REPORTED THAT THE SITE WAS HOT, SWOLLEN AND RED. THE PROVIDER PRESCRIBED A 7-DAY ANTIBIOTIC REGIMEN (KEFLEX). THE PATIENT WAS DIRECTED TO CONTACT THEIR IMPLANTED PHYSICIAN. ON (B)(6) 2023, THE PATIENT WAS SEEN BY THE PHYSICIAN ASSISTANT AGAIN AND WAS INSTRUCTED TO FINISH THE ANTIBIOTICS. ON (B)(6) 2023, THE PATIENT CALLED TO REPORT CONTINUED SIGNS OF AN INFECTION. THEY WERE PRESCRIBED A SECOND ROUND OF ANTIBIOTICS (DOXYCYCLINE) BUT HAD TO STOP TREATMENT DUE TO AN ALLERGIC REACTION. ON (B)(6) 2023, THE PATIENT WAS SEEN BY A COMPANY REPRESENTATIVE. THE COMPANY REPRESENTATIVE WAS INFORMED BY MEDICAL STAFF THAT THE PATIENT MAY HAVE AN INFECTED INCISION. PATIENT WAS PUT A THIRD ROUND OF ANTIBIOTICS (KEFLEX). ON (B)(6) 2023, THE PATIENT WAS SEEN BY IMPLANTING PHYSICIAN WHO CONFIRMED THAT THE INFECTION WAS CLEARED. PATIENT WAS ACTIVATED ON (B)(6) 2023. THERE WERE NO RELAT

  Patient problems: Cellulitis; Skin Inflammation/ Irritation

  MAUDE report 17046441 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  80 YEAR OLD FEMALE WAS IMPLANTED ON (B)(6) 2023. THEY WERE SEEN AT THEIR 2 WEEK WOUND HEALING CHECK AS WELL THEIR 4 WEEK ACTIVATION APPOINTMENT. THERE WERE NO ISSUES NOTED RELATED TO HEALING OF THE INCISION. ON (B)(6) 2023, THEY WERE SEEN BY THE IMPLANTING PHYSICIAN AND PRESENTED WITH CLEAR SIGNS OF INFECTION AT THE INCISION SITE (I.E. REDNESS AND SORENESS). ADDITIONALLY, THE IMPLANT WAS VISIBLE. THE PHYSICIAN EXPLANTED THE DEVICE. THE PATIENT'S WOUND WAS DEBRIDED, IRRIGATED AND PACKED AND THEY WERE PRESCRIBED ANTIBIOTICS. PATIENT WAS REFERRED TO A WOUND CLINIC. AN UPDATE WAS RECEIVED ON 04/24/2023 CONFIRMING THE PATIENT IS UNDER THE CARE OF A WOUND CLINIC. NO FURTHER ISSUE REPORTED RELATED TO HEALING OF THE SITE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16828341 ↗