remede EL System Implantable Pulse Generator IS-1 1100Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00857688007391), received between Oct 30, 2025 and Aug 27, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Compatibility 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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient with history of large B-cell lymphoma was hospitalized on (b)(6) 2026 for confusion, worsening tremors, and hypervolemia. Patient was in need of MRI and ZOLL Respicardia was notified and interrogated the remedy system (b)(6) 2026. Testing revealed high impedance on 2 electrodes and providers were informed that the device is no longer considered MRI conditional due to high impedance. During the course of hospitalization, CBC with differential was reported as abnormal on (b)(6) 2026 and blood cultures were obtained. Blood culture results on (b)(6) 2026 reported gram (+) cocci in pairs and chains identified as Enterococcus gallinarum. Due to new finding of bacteremia and lead previously found to have high impedance and device is no longer considered MRI conditional; provider made the decision to explant the remedy system. The system was explanted on (b)(6) 2026 and provider noted that inspection of the pocket showed no evidence of infection.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50478567 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED AT (B)(6) WITH THE REMEDE SYSTEM ON (B)(6) 2025. PATIENT WAS SCHEDULED TO HAVE THERAPY ACTIVATED IN (B)(6) 2026 BUT APPOINTMENT WAS CANCELED DUE TO SNOWSTORM. PATIENT WAS RESCHEDULED FOR (B)(6) 2026 BUT PATIENT WAS HOSPITALIZED AT UVM DUE TO A FALL. PATIENT'S PROVIDER CONTACTED ZOLL RESPICARDIA REPRESENTATIVE ON (B)(6) 2026 TO INFORM THAT HOSPITALIST AT UVM HAD CONTACTED HER TO ADVISE THAT PATIENT DEVELOPED URINARY RETENTION AND MRI WAS NEEDED TO RULE OUT SPINAL CORD COMPRESSION. PROVIDER REQUESTED THAT ZOLL RESPICARDIA REPRESENTATIVE GO TO UVM TO CHECK THE REMEDE SYSTEM DEVICE. ON (B)(6) 2026, HOSPITALIST AT (B)(6) CONTACTED ZOLL RESPICARDIA REPRESENTATIVE DIRECTLY TO INFORM THAT THE PATIENT WAS POSITIVE FOR BACTEREMIA AND CULTURES ARE POSITIVE FOR MRSA. EMAIL COMMUNICATIONS BETWEEN HOSPTIALIST AND PROVIDER NOTES AN ULCER (CRANIAL LEFT, CAUDAL RIGHT) THAT APPEARED TO BE HEALING WELL AND SURROUNDING POCKET LOOKS OK BUT WITH 2/2 BLOOD CULTURES TESTING POSITIVE FOR MRSA, THERE IS CONCERN THAT THE DEVICE IS A POTENTIAL SOURCE AND HAVING ID TEAM ASSESS AS WELL AND TREATING WITH VANCOMYCIN IN THE MEANTIME. ULTRASOUND SHOWED FEATURES CONCERNING FOR ABSCESS UNDER THE

  Patient problems: Post Operative Wound Infection

  MAUDE report 24793575 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT DEVELOPED A POCKET INFECTION FOLLOWING THE (B)(6) 2025 IMPLANT, PROMPTING PRECAUTIONARY EXPLANT OF THE REMED SYSTEM ON (B)(6) 2026. NO SYSTEMIC SIGNS OF INFECTION WERE REPORTED, NO IMAGING WAS PERFORMED, AND THE PATIENT IS NOT RECEIVING INFECTION RELATED TREATMENT, WITH RE-IMPLANTATION PLANNED IN A FEW MONTHS. THE IPG AND LQS LEAD WILL BE RETURNED FOR ANALYSIS, AND THE DISTAL LEAD TIP WAS REMOVED AND SENT FOR CULTURE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24443702 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LEAD REVISION ON (B)(6) 2025, THE PATIENT DEVELOPED REDNESS AND SWELLING AT THE DEVICE POCKET BEGINNING IN MID (B)(6). THESE SYMPTOMS PROGRESSED, AND THE PATIENT UNDERWENT A POCKET REVISION ON (B)(6) 2025. AT THE FOLLOW UP VISIT ON (B)(6) 2026, PERSISTENT ERYTHEMA AND SWELLING WERE AGAIN NOTED, AND THERAPY ACTIVATION WAS POSTPONED. NO DEVICE MALFUNCTION WAS IDENTIFIED, AND THE PATIENT'S CONDITION WAS REPORTED TO BE IMPROVING. ON 29JAN2026, PARTIAL CLINICAL INFORMATION WAS RECEIVED FROM THE SITE, INCLUDING A WOUND CULTURE RESULT SHOWING FEW STAPHYLOCOCCUS EPIDERMIDIS, CONFIRMATION THAT LABORATORY TESTING HAD BEEN PERFORMED (VALUES NOT PROVIDED), CONTINUED IMPROVEMENT IN POCKET APPEARANCE, NO ADDITIONAL PROCEDURES PLANNED, AND A SCHEDULED FOLLOW UP VISIT. ADDITIONAL DOCUMENTATION FROM THE SITE REMAINS PENDING. CLINICAL SAFETY REVIEWED THE SUBMITTED INFORMATION ON 30JAN2026. BASED ON AVAILABLE RECORDS, THE ADVERSE EVENT REPRESENTS A CONTINUATION OF THE SAME POCKET COMPLICATION THAT BEGAN IN MID (B)(6) AND REQUIRED THE POCKET REVISION ON (B)(6) 2025. BECAUSE THE EVENT RESULTED IN A SURGICAL INTERVENTION, IT MEETS CRITERIA FOR A SERIOUS ADVERSE EVENT (SAE). NO DEVICE MALFUNC

  Patient problems: Post Operative Wound Infection

  MAUDE report 24273487 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT DEVELOPED A POCKET INFECTION AFTER REMEDE DEVICE IPG AND LEAD CHANGE OUT (B)(6) 2023. PATIENT TREATED WITH ORAL ANTIBIOTICS FOR ROUGHLY 6 WEEKS WITHOUT RESOLUTION OF THE POCKET INFECTION. ON (B)(6) 2023, ZOLL RESPICARDIA PERSONNEL WERE NOTIFIED THAT A POCKET REVISION WOULD BE PERFORMED ON THE PATIENT. ON (B)(6) 2023, THE PATIENT UNDERWENT A PROCEDURE TO HAVE A TYRX ANTIBACTERIAL POUCH PLACED AROUND THE IPG AFTER THE POCKET WAS SWABBED WITH VANCOMYCIN. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2023 FOR THERAPY REACTIVATION AND WOUND CHECK. PATIENT STATES THE INCISION SITE IS HEALING WELL. THERE IS NO TENDERNESS, NOR IS THE WOUND SITE ITCHING. THERE IS NO ACTIVE DRAINAGE. THE PATIENT IS CURRENTLY COMPLETING THEIR PRESCRIPTION FOR 100 MG DOXYCYCLINE FOR 10 DAYS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24262087 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 DR. (B)(6) AND DR. (B)(6) EXPLANTED THE REMEDE IPG (B)(6) AND BOTH STIMULATION (REMEDE SYSTEM 4065-00220) AND THE SENSING LEAD (ABBOTT 1258T-75). THE POCKET WAS CLEANED USING A WOUND VAC AND THEN CLOSED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24262007 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 PATIENT WAS IMPLANTED WITH A REMEDE DEVICE. ON AN UNKNOWN DATE THE PATIENT WAS SEEN IN THE PHYSICIAN OFFICE FOR A WOUND CHECK. ON (B)(6) 2023 NOTIFICATION FROM THE PHYSICIAN TO FIELD TEAM THAT THE PATIENT REQUIRED AN EXPLANT OF THE REMEDE DEVICE 11/14/2023 DUE TO A POCKET INFECTION. FURTHER DETAILS ARE PENDING. NO ZOLL RESPICARDIA PERSONNEL WAS PRESENT AT THE EXPLANT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24261771 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  FROM REPORTER "PT RETURNED TO RECOVERY SUITE FOLLOWING REMEDE PLACEMENT WHERE HE WAS NOTED TO HAVE A HEMATOMA ON HIS RIGHT CHEST. A NURSE HELD MANUAL PRESSURE UNTIL IMPLANTING PHYSICIAN DR. (B)(6) MADE IT TO BEDSIDE AND ORDERED A PRESSURE DRESSING. THE PATIENT'S HEART RATE BRAIDED DOWN INTO THE 20S AND HE BECAME UNRESPONSIVE. A CODE BLUE WAS CALLED AND THE PATIENT DID REGAIN CONSCIOUSNESS BUT WAS STILL HYPOTENSIVE AND BRADYCARDIC. HE WAS TRANSFERRED TO THE ICU WHERE VITALS STABILIZED. HE WAS DISCHARGED HOME ON (B)(6) 2023.

  Patient problems: Hematoma

  MAUDE report 24203371 ↗
• InjuryJan 28, 2026Compatibility Problem

  PATIENT HAD A PREEXISTING MEDTRONIC CRT-D. PATIENT WAS IMPLANTED WITH A REMEDE DEVICE ON (B)(6) 2023 WITH NO CROSS TALK BETWEEN THE DEVICES NOTED AND THERAPY ACTIVATION OCCURRED ON (B)(6) 23. ON (B)(6) 2023 PATIENT HAD AN RV LEAD INTEGRITY ALERT FROM MEDTRONIC CRT-D. PATIENT WAS ADMITTED TO THE HOSPITAL FOR EVALUATION AND THE REMEDE DEVICE WAS PUT INTO MONITOR MODE ONLY (NO THERAPY BEING GIVEN). ON (B)(6) 2023 THE REMEDE REPRESENTATIVE AND MEDTRONIC REPRESENTATIVE MET AT THE PATIENT'S ROOM TO RUN TESTING. THE MEDTRONIC REPRESENTATIVE ADJUSTED THE CRT-D SENSING LEAD AND IT FELT COMFORTABLE. THE EP REQUESTED AND LOOKED OVER THE CXR TO VISUALLY EVALUATE THE INTEGRITY OF THE LEAD FOR ANY POSSIBLE ISSUES AND DID NOT SEE ANYTHING CONCERNING. THE REMEDE DEVICE REMAINED IN MONITOR MODE WHERE THE PATIENT WAS DISCHARGED ON (B)(6) 2023. ON (B)(6) 2024 THE PATIENT WAS SEEN BY THE REMEDE REPRESENTATIVE AND MEDTRONIC REPRESENTATIVE AT THE PHYSICIAN OFFICE. DEVICE TESTING WAS DONE WITH NO CONCOMITANT INTERACTION NOTED AT THIS PROGRAMMED THERAPY. THE THERAPY WAS LEFT ON. ON (B)(6) 2024 THE REMEDE REPRESENTATIVE WAS MADE AWARE THE PATIENT WAS HAVING ANOTHER RV LEAD INTEGRITY ALERT TAKING PLACE. THE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24202904 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, PATIENT IMPLANTED WITH A REMEDE SYSTEM. PATIENT HAS AN EXISTING CRT-D. ON (B)(6) 2024 PATIENT WAS ADMITTED TO THE HOSPITAL WITH SEPSIS EVOLVING INTO SEPTIC SHOCK DUE TO MMSA BACTERMIA. A SMALL MOBILE ECHODENSITY LIKELY REPRESENTING A VEGETATION OR THROMBUS APPEARS ATTACHED TO AN ICD LEAD. ON (B)(6) 2024, PATIENT HAD THE REMEDE SYSTEM AND CRT-D EXPLANTED DUE TO SEPSIS. ICD TIP CULTURE RESULTS SHOW NO GROW, PATIENT HAD BEEN ON ANTIBIOTICS. POST PROCEDURE PATIENT WAS HYPOTENSIVE REQUIRING PRESSORS AND ICU TRANSFER. ON (B)(6) 2024 PATIENT WAS DISCHARGED FROM HOSPITAL ON ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24164327 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT HAD A SUCCESSFUL ELECTIVE EXPLANT OF HER REMEDE SYSTEM DUE TO POCKET PAIN AND ERS AFTER A FALL. ON (B)(6) 2024, THE PATIENT DEVELOPED SIGNIFICANT TENDERNESS OVER THE EXPLANT SITE WITH SOME SWELLING. ON (B)(6) 2024, THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT FOR PAIN AND SWELLING WAS NOTED TO HAVE A HEMATOMA. THE PATIENT HEMATOMA WAS TREATED WITH A PRESSURE DRESSING AND SHE WAS GIVEN NORCO AND DILAUDID FOR PAIN. THE PATIENT HGB DROPPED FROM 12.6-8.6 AND SHE WAS ADMITTED OVERNIGHT. HGB STABILIZED AND THE PATIENT WAS DISCHARGE ON (B)(6) 2024.

  Patient problems: Hematoma

  MAUDE report 24164032 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 THE PATIENT WAS IMPLANTED WITH THE REMEDE SYSTEM. ON (B)(6) 2022 THE PATIENT HAD AN IPG CHANGE OUT FOR BATTERY EOL. ON (B)(6) 2024 THE PATIENT HAD AN IPG CHANGE OUT FOR BATTERY EOL. ON (B)(6) 2024 THE PATIENT HAD THE ENTIRE REMEDE SYSTEM EXPLANTED DUE TO A POCKET INFECTION. NO OTHER DETAILS ARE CURRENTLY AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24163906 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE IN 2024, AN (B)(6) Y.O. MALE STATUS POST ZOLL RESPICARDIA REMEDE CENTRAL SLEEP APNEA DEVICE IMPLANTED IN (B)(6) 2023 PRESENTED WITH COMPLAINTS OF RIGHT ARM SWELLING. AN ULTRASOUND WAS DONE ON AN UNKNOWN DATE IN 2024 THAT SHOWED THE FOLLOWING: RIGHT UPPER EXTREMITY DEEP VEINS: INTERNAL JUGULAR: PATENT. SUBCLAVIAN: NEARLY OCCLUSIVE THROMBUS. AXILLARY: OCCLUSIVE THROMBUS. BRACHIAL: PATENT AND COMPRESSIBLE. RIGHT UPPER EXTREMITY SUPERFICIAL VEINS. BASILIC: PATENT AND COMPRESSIBLE. CEPHALIC: PATENT AND COMPRESSIBLE. ON (B)(6) 2024 THE PATIENT WAS EVALUATED BY THE REMEDE IMPLANTING PHYSICIAN WHO INDICATED THE PATIENT STATED THE RIGHT ARM SWELLING HAD IMPROVED AFTER INITIATION OF ELIQUIS 5 MG TWICE A DAY. ON (B)(6) 2024 THE PATIENT REMEDE SYSTEM WAS SUCCESSFULLY EXPLANTED PER PATIENT PREFERENCE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24096039 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A REMEDE SYSTEM ON (B)(6) 2024. ON (B)(6) 2024, PATIENT HAD SUCCESSFUL THERAPY ACTIVATION. ON (B)(6) 2024, PATIENT WAS EVALUATED IN THE OFFICE BY (B)(6), FNP FOR THERAPY CHANGES. AVAILABLE NOTES DO NOT MENTION ANY POSSIBLE INFECTION. ON (B)(6) 2024, PATIENT PRESENTED VIRTUALLY TO THE IMPLANT CENTER WITH A SWOLLEN AND SOMEWHAT RED POCKET. PATIENT WAS SCHEDULED FOR AN APPOINTMENT ON (B)(6) 2024. ON (B)(6) 2024, PATIENT HAD BLOODWORK AND THE REMEDE SYSTEM REMOVED DUE TO SUSPECTED POCKET INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24084709 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A REMEDE SYSTEM ON (B)(6), 2022 BY DR. (B)(6). ON (B)(6) 2024 THE PATIENT UNDERWENT AN IPG CHANGE OUT FOR BATTERY END OF LIFE. AFTER THE IPG CHANGE OUT, ON AN UNKNOWN DATE, THE PATIENT DEVELOPED A POCKET INFECTION REQUIRING A SYSTEM EXPLANT ON (B)(6) 2024. NO ADDITIONAL DETAILS ARE AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24023571 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 THE PATIENT WAS IMPLANTED WITH A REMEDE SYSTEM FOR CENTRAL SLEEP APNEA AT THE (B)(6) BY DR. (B)(6). ON (B)(6) 2024 THE PATIENT THERAPY WAS SUCCESSFULLY ACTIVATED. ON (B)(6) 2024 THE PATIENT CAME IN FOR A SCHEDULED APPOINTMENT. AT THAT TIME THE PATIENT MENTIONED THAT HE FELT THE DEVICE IMPLANTABLE GENERATOR WAS MIGRATING IN THE POCKET. THE IMPLANTING PHYSICIAN EVALUATED THE POCKET AND FELT THERE WAS A POCKET EROSION CAUSING THE NEED FOR A REVISION OF THE POCKET WHICH IS SCHEDULED FOR (B)(6) 2025.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24023305 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 PATIENT REPORTED THAT HE "WOKE UP AND THE SHEETS WERE DRENCHED, DIDN'T REMEMBER SEEING ANYTHING WRONG WITH THE INCISION PRIOR TO THAT DAY" THE PATIENT STATED HE DID SEE SOME REDNESS AROUND THE POCKET IN (B)(6) 2024. ON (B)(6) 2025 THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAS LOST WEIGHT WHICH MAY HAVE LED TO THE EROSION. CULTURE RESULTS ARE PENDING. NO INFORMATION IF ANTIBIOTICS WERE STARTED. ON (B)(6) 2025 THE FIELD TEAM WAS SHOWN A PICTURE OF THE POCKET. FIELD PERSONNEL VERIFIED THE DEVICE HAD ERODED THROUGH THE SKIN. THE PLAN WAS TO EXPLANT THE WHOLE SYSTEM. ON (B)(6) 2025 THE ENTIRE REMEDE SYSTEM WAS EXPLANTED WITHOUT INCIDENCE.

  Patient problems: Pocket Erosion

  MAUDE report 24022100 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, PATIENT WAS IMPLANTED WITH THE REMEDE DEVICE. PATIENT HAD AND INFLAMMATORY RESPONSE TO THE AQUACEL AND DERMABOND DRESSING THAT WAS APPLIED TO WOUND DURING IMPLANT. PATIENT WAS TREATED WITH TOPICAL HYDROCORTISONE BUT STARTED TO DEVELOP A PURULENT DISCHARGE, PT. FELT UNWELL AND HAD LOW GRADE FEVERS. PATIENT COMPLETED A COURSE OF ANTIBIOTICS BUT SYMPTOMS WORSENED. GIVEN THE LOW-GRADE FEVERS, HISTORY OF PURULENT DRAINAGE, AND WORSENING CLINICAL COURSE DESPITE ANTIBIOTICS, SYSTEM WAS EXPLANTED DUE TO HIGH SUSPICION OF DEVICE INFECTION. THE REMEDE SYSTEM DEVICE WAS EXPLANTED ON (B)(6) 2025 AND CULTURES WERE OBTAINED FROM THE IPG POCKET. ON (B)(6) 2025 IT WAS REPORTED THAT THE CULTURE RESULTS WERE MRSA+.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23976420 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED ON (B)(6) 2025. PATIENT WAS SEEN IN FOLLOW UP FOR THERAPY ACTIVATION ON (B)(6) 2025 AND A SMALL SCAB WAS NOTED AT INCISION SITE AMD PROVIDER NOTED THAT THE SITE LOOKED GOOD. PATIENT WAS TO BE SEEN FOR FOLLOW UP ON (B)(6) 2025 BY OUR TEAM BUT DID NOT SHOW FOR SCHEDULED APPOINTMENT. PATIENT'S PROVIDER REACHED OUT TO THE PATIENT ON (B)(6) 2025 AND THE PATIENT. INFORMED THE PROVIDER THAT THE SYSTEM WAS EXPLANTED ON (B)(6) 2025. THE PATIENT ALSO INFORMED THE PROVIDER THAT HE HAD DEVELOPED AN INFECTION AND THE POCKET WAS OPENING AND YOU COULD SEE THE WIRES. ANTIBIOTICS WERE PRESCRIBED BUT THE INFECTION DID NOT RESOLVE. PATIENT WENT TO THE ER DUE TO FLUID DRAINAGE AT INCISION SITE AND THE ER PHYSICIAN RECOMMENDED HE HAVE THE DEVICE. REMOVED FOR FEAR OF SEPSIS. AS WE WERE NOT PRESENT AT THE EXPLANT, OUR TEAM REACHED OUT TO THE IMPLANTING EP FOR FURTHER DETAILS AND EP NOTED THAT THE CULTURES OBTAINED DURING EXPLANT WERE NEGATIVE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23976139 ↗
• InjuryDec 17, 2025Compatibility Problem; Compatibility Problem

  ZOLL RESPICARDIA RECEIVED AN EMAIL FROM PATIENT ALLEGING INJURY DUE TO CONCOMITANT DEVICE INTEGRATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23831738 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED ON (B)(6) 2025. PATIENT WAS SEEN FOR FOLLOW-UP ON (B)(6) 2025 AND FOUND TO HAVE A POCKET INFECTION AND PENDING SYSTEM REMOVAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23778052 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO PHYSICIAN'S OFFICE ON (B)(6) 2025 WITH COMPLAINTS OF PAIN AT IMPLANT SITE. ANTIBIOTICS WERE PRESCRIBED DURING ON (B)(6) 2025 VISIT. DURING ON (B)(6) 2025 VISIT, IT WAS NOTED THAT PATIENT DID NOT START THE ANTIBIOTICS THAT WERE PRESCRIBED ON (B)(6) 2025 AND IT WAS NOTED THAT THE INCISION IS NOW DRAINING. THE PATIENT WAS DIRECTLY ADMITTED TO THE HOSPITAL FROM THE OFFICE. INFECTIOUS DISEASE WAS CONSULTED AND DIAGNOSED PATIENT WITH A POCKET INFECTION REQUIRING REMEDE SYSTEM EXPLANT. THE REMEDE SYSTEM WAS EXPLANTED ON (B)(6) 2025. BLOOD CULTURES WERE COLLECTED ON (B)(6) 2025 AND SHOWED NO GROWTH AT 5 DAYS. CULTURES OF THE IPG POCKET WERE COLLECTED ON (B)(6) 2025 AND WERE POSITIVE FOR MSSA. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025 AND PRESCRIBED LINEZOLID 600 MG Q 12 HOURS FOR 7 DAYS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23427438 ↗