CanGaroo Envelope CMCV-009-LRGRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00859389005065), received between Oct 5, 2016 and Sep 26, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Unspecified Infection

  MAUDE report 50907236 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL FROM ELUTIA SALES REPRESENTATIVE REPORTING "EROSION OF DEVICE." MALE PATIENT HAD NEW BIV PACER IMPLANTED (B)(6) 2023 USING THE CANGAROO ENVELOPE (MODEL # CMCV-009-LRG, LOT # M21G1274). BOTH BIV PACER AND CANGAROO ENVELOPE WERE EXPLANTED (B)(6) 2023 DUE TO EROSION OF THE DEVICE. PHYSICIAN REPORTED THE POSSIBLE CAUSE OF THE EVENT AS "[FELLOW] HAS ONLY IMPLANTED A CANGAROO ONCE, USED IT FOR AN ELDERLY PATIENT THAT HAD THIN SKIN, NOT SURE WHAT TO THINK, MAYBE THE FELLOW'S TECHNIQUE CLOSING THE POCKET COULD HAVE SOMETHING TO DO WITH IT." HE FURTHER STATED THAT BECAUSE THIS WAS THE FIRST TIME HE HAD HAD A CANGAROO PLACED IN A PATIENT, AND THE FELLOW HAD NOT PREVIOUSLY USED ONE OR BEEN TRAINED ON ITS IMPLANTATION, HE COULD NOT SPEAK TO REMODELING, MIGRATION, OR EROSION WITH THE USE OF THIS DEVICE. EVENT RELATIONSHIP TO BOTH PROCEDURE AND AZIYO DEVICE REPORTED AS "POSSIBLY RELATED." PATIENT RECEIVED MEDICATION IN ADDITION TO EXPLANT, IS REPORTED AS DOING WELL, AND IS SCHEDULED TO HAVE PACEMAKER IMPLANT ON CONTRALATERAL SIDE.

  Patient problems: Pocket Erosion

  MAUDE report 18344337 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL RESEARCH MANAGER OF CANGAROO STUDY REPORTED PATIENT ADVERSE EVENT AS FOLLOWS: ON (B)(6) 2021, PATIENT RECEIVED DE NOVO IMPLANT OF A BIVENTRICULAR PACEMAKER AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (BIV AICD) WITH CANGAROO ENVELOPE (MODEL CMCV-009-LRG, LOT NUMBER M21E1177636). ON FOLLOW-UP VISIT (B)(6) 2022, PATIENT HAD SIGNS OF INFECTION AT IMPLANT SITE AND WAS ADMITTED TO THE HOSPITAL. DEVICE EXPLANTED ON (B)(6) 2022 AND PATIENT STARTED ON CEPHALEXIN. PHYSICIAN REPORTED THAT PATIENT HAD A WOUND DEHISCENCE WHICH RESULTED IN POCKET INFECTION. PHYSICIAN REPORTED THAT EVENT WAS "PROBABLY RELATED" TO THE IMPLANT PROCEDURE. PATIENT IS MALE, (B)(6).

  Patient problems: Hematoma; Unspecified Infection; Wound Dehiscence

  MAUDE report 13443917 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL RECEIVED FROM PHYSICIAN DESCRIBING THE FOLLOWING EVENT: PATIENT UNDERWENT A LEAD REVISION PROCEDURE FROM A PRIOR ICD PLACEMENT ON (B)(6) 2021 UTILIZING AN AZIYO CANGAROO ENVELOPE (CMCV-009-LRG, LOT #M21C1109). ON (B)(6) 2021, PATIENT REPORTED POCKET PAIN AND SWELLING WHICH WAS OBSERVED AT PHYSICIAN'S OFFICE. ON (B)(6) 2021, PATIENT WAS REEVALUATED AND SENT FOR SEROMA EXTRACTION, AT WHICH TIME A PURULENT WHITE MATERIAL WITHOUT ODOR WAS EXTRACTED FROM THE POCKET. BLOOD CULTURES AND WOUND CULTURES WERE NEGATIVE. ICD AND LEADS REMOVED. PATIENT HOSPITALIZED AND INFECTIOUS DISEASE SERVICE CONSULTED. PATIENT PLACED ON IV ANTIBIOTICS AND CLEARED FOR RE-IMPLANT ON (B)(6) 2021.

  Patient problems: Seroma

  MAUDE report 13294315 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL FROM CLINICAL RESEARCH MANAGER REGARDING A PATIENT WHO HAD THE REMOVAL OF COMPLETE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) SYSTEM, INCLUDING THE AZIYO CANGAROO DEVICE ON (B)(4) 2021. IT WAS REMOVED DUE TO A LEFT-SIDED POCKET HEMATOMA AND A RECENT HISTORY OF INFECTION IN PREVIOUS RIGHT-SIDED POCKET, WITHOUT INDICATION OF INFECTION OF CURRENT SITE. ON (B)(6) 2021, HE WENT TO THE EMERGENCY DEPARTMENT DUE TO LEFT POCKET DRAINING SANGUINEOUS DRAINAGE AND SLIGHTLY DEHISCED OPENING. HE WAS PLACED ON VANCOMYCIN/CEFEPIME IV. DRAINAGE CHANGED FROM SANGUINEOUS TO SEROUS, NO PURULENCE. PATIENT WAS AFEBRILE THROUGHOUT HOSPITAL STAY WITH ONE EXCEPTION IN EMERGENCY DEPARTMENT OF 100.5 DEGREES FAHRENHEIT. ON (B)(6) 2021, DEVICE WAS EXPLANTED.

  Patient problems: Hematoma

  MAUDE report 12770641 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN AZIYO SALES REP THAT A PATIENT WITH A CARDIOVASCULAR IMPLANTABLE ELECTRICAL DEVICE (CIED) WITH ACCOMPANYING AZIYO CANGAROO ENVELOPE (MODEL CMCV-009-LRG, LOT M21D1128(065)) HAD AN EXPLANT OF BOTH DEVICES DUE TO POCKET INFECTION ON (B)(6) 2021. DATE OF ORIGINAL IMPLANT WAS (B)(6) 2021. PATIENT EXPERIENCED EARLY POST-OPERATIVE PAIN AND APPROXIMATELY A WEEK LATER HAD PUS DRAINING FROM THE INCISION. PHYSICIAN DOES NOT BELIEVE THE AZIYO DEVICE WAS THE CAUSE OF THE INFECTION BUT IT CANNOT BE RULED OUT. NEW PLACEMENT OF CIED SYSTEM PLANNED AT A LATER DATE ON CONTRALATERAL SIDE. ACCOMPANYING IMPLANTED/EXPLANTED DEVICE WAS BIOTRONIK ACTICOR 7VR-T DX.

  Patient problems: Unspecified Infection

  MAUDE report 12675139 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 24, 2021, AZIYO WAS NOTIFIED BY BUSINESS PARTNER BOSTON SCIENTIFIC THAT A PATIENT WITH A CARDIAC IMPLANTABLE ELECTRONIC DEVICE AND AZIYO BIOLOGICS CANGAROO ENVELOPE (MODEL CMCV-009-LRG, LOT NUMBER M21C1118(546), BOTH IMPLANTED ON (B)(6) 2021, PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2021 WITH A POCKET INFECTION. THE PATIENT WAS STARTED ON IV CLINDAMYCIN AND VANCOMYCIN. THE AZIYO ENVELOPE DEVICE WAS EXPLANTED AS PART OF A POCKET REVISION ON (B)(6) 2021. CULTURES OF THE POCKET TAKEN AT THE TIME OF EXPLANT SHOWED "NO GROWTH" ON DAY 3. DEVICE REIMPLANTED ON CONTRALATERAL SIDE ON (B)(6) 2021. EXPLANT SITE LOOKED GOOD AND DRAIN REMOVED AT THAT TIME. PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Bacterial Infection

  MAUDE report 12672390 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, AZIYO WAS NOTIFIED BY BUSINESS PARTNER BOSTON SCIENTIFIC THAT A PATIENT WITH A BIVENTRICULAR PACEMAKER (BIV) IMPLANTED ON (B)(6) 2021 AND AZIYO BIOLOGICS CANGAROO ENVELOPE (MODEL CMCV-009-LRG, LOT NUMBER M19L1435) PRESENTED WITH POCKET INFECTION. THE AZIYO DEVICE WAS EXPLANTED AS PART OF THE REMOVAL OF THE ENTIRE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) SYSTEM ON (B)(6) 2021. PATIENT WAS TREATED WITH IV ANTIBIOTICS AND HAD A NEW DEVICE WITH AZIYO ENVELOPE REIMPLANTED ON (B)(6) 2021. PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Unspecified Infection

  MAUDE report 12568418 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 PATIENT HAD ICD IMPLANTED ALONG WITH AZIYO ENVELOPE CMCV-009-LRG, LOT # M21E1181. ON (B)(6) 2021 PATIENT RETURNED TO FACILITY WITH SUPERIOR MARGINS DEHISCENCE OF ICD POCKET NOTED AND EXPLANT PERFORMED. PATIENT WAS TREATED WITH MULTIPLE IV ANTIBIOTICS INCLUDING CEFAZOLIN, CEFTRIAXONE, VANCOMYCIN AND NAFCILLIN FOR MSSA INFECTION. ACCORDING TO THE CATH LAB, THE AZIYO DEVICE WAS REMOVED BECAUSE THE ICD SYSTEM WAS REMOVED. THE AZIYO DEVICE WAS NOT BELIEVED TO BE THE PRIMARY PRODUCT REQUIRING EXPLANTATION OF THE SYSTEM.

  Patient problems: Sepsis

  MAUDE report 12541836 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 01MAR2021 BY AZIYO SALES REPRESENTATIVE THAT THE PATIENT HAD A SUCCESSFUL ICD GENERATOR CHANGE-OUT ON (B)(6) 2021 USING A CANGAROO ENVELOPE (MODEL #: CMCV-009-LRG; LOT #: M20G1216) HAVING BEEN SOAKED IN SALINE FOR 1 - 2 MINUTES. FOLLOWING THE IMPLANT, THE PATIENT WAS SUBSEQUENTLY ADMITTED TO ANOTHER HOSPITAL FOR 3 WEEKS FO AN AORTIC VALVE REPAIR. THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION AS THR DOCTOR REPORTED ICD WOUND WAS DRAINING YELLOW PUS AND PATIENT TESTED POSITIVE FOR PSEUDOMONAS INFECTION SO PATIENT WAS PLACED ON IV ANTIBIOTICS. ON (B)(6) 2021, THE ICD DEVICE AND 21-YEAR-OLD LEADS WERE SUCCESSFULLY EXPLANTED AND PATIENT REPORTEDLY DOING WELL. UNKNOWN IF ENVELOPE WAS EXPLANTED WITH THE EXPLANT OF THE ICD. NO FURTHER DETAILS WERE AVAILABLE FOR THIS EVENT, SHOULD AZIYO RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Bacterial Infection; Post Operative Wound Infection

  MAUDE report 11584730 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL CMCV-009-LRG LOT #M20D1129) WAS USED WITH A BOSTON SCIENTIFIC PULSE GENERATOR (MODEL # / SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. IT WAS REPORTED BY BSC THAT ON 10/14/2020 THE PULSE GENERATOR DEVICE AND LEAD WERE EXPLANTED DUE TO POCKET INFECTION WITH SEPSIS AS WELL AS THE AZIYO PRODUCT. THE DEVICE AND LEADS WILL NOT BE RETURNED FOR ANALYSIS. UNKNOWN IF ANTIBIOTICS WERE GIVEN. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS BY BOSTON SCIENTIFIC ON 10/21/2020.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 10861950 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL # CMCV-009-LRG, LOT# M20A1044) WAS IMPLANTED WITH A BOSTON SCIENTIFIC CRT-D (MODEL# / SERIAL # - UNKNOWN). IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NORMAL SHOCK LEAD IMPEDANCES (SLI) FOR FOUR DAYS AFTER COMPLETION OF A DEVICE CHANGE OUT. AT WHICH TIME, THE SLI WENT GREATER THAN 200 OHMS AND REMAINED THERE. THE PHYSICIAN WENT BACK INTO THE POCKET AND ALL CONNECTIONS INCLUDING THE SET SCREW WERE NORMAL. IT WAS NOTED THAT THIS PATIENT HAD A CANGAROO POUCH THAT HAD A SLIGHT AMOUNT OF FLUID BETWEEN THE POUCH AND THE POCKET. IT WAS QUESTIONED WHETHER THE FLUID MIGHT BE CONTRIBUTING TO THE IMPEDANCE MEASUREMENTS. A SYNCHRONIZED SHOCK WAS PERFORMED AND SLI MEASUREMENT WAS 84 OHMS. HOWEVER, THE PAINLESS TEST MEASUREMENT IS GREATER THAN 200 OHMS. THE PLAN WAS TO REPLACE THE CANGAROO POUCH, TURN OFF SLI MEASUREMENTS AND CONTINUE TO MONITOR. AT THIS TIME THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NEITHER THE INITIAL IMPLANT DATE, NOR THE CONFIRMED EXPLANT DATE WERE PROVIDED

  Patient problems: Seroma

  MAUDE report 10460808 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL CMCV-009-LRG, LOT #M19M1492) WAS USED WITH A BOSTON SCIENTIFIC PULSE GENERATOR (MODEL # / SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. PATIENT DEVELOPED AN INFECTION WITH SEPSIS AND HAD HIS PULSE GENERATOR AND LEADS EXPLANTED ON (B)(6) 2020. THE EXTRACTION INCLUDED THE AZIYO ENVELOPE. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS BY BOSTON SCIENTIFIC ON (B)(6) 2020 WITH ADDITIONAL DETAIL PROVIDED (B)(6) 2020.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 10255877 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER, BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL #CMCV-009-LRG, LOT #M20A1044) WAS USED WITH A BOSTON SCIENTIFIC CIED (MODEL # / SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PHYSICIAN WAS REMOVING A SCAB FROM THE INCISION LINE WHICH RESULTED IN AN OPENING OF THE INCISION. HENCE, THE PHYSICIAN PERFORMED A POCKET REVISION. THE ENTIRE SYSTEM REMAINED IN SERVICE INCLUDING THE AZIYO CANGAROO ENVELOPE. THERE WERE NO ADDITIONAL PATIENT EFFECTS REPORTED. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS ON 06/09/2020 BY BOSTON SCIENTIFIC, WITH ADDITIONAL DETAILS PROVIDED ON 07/09/2020.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10255874 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL CMCV-009-LRG LOT# M20A1024) WAS USED WITH A BOSTON SCIENTIFIC CIED (MODEL # / SERIAL # UNKNOWN) ON (B)(6) 2020. THE PATIENT HAD HIS PRODUCT EXPLANTED ON (B)(6) 2020 DUE TO AN INFECTION WITH SEPSIS. INTRAVENOUS ANTIBIOTICS WERE GIVEN TO TREAT THE INFECTION.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 10202363 ↗
• InjuryJun 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN AZIYO CANGAROO ENVELOPE (MODEL CMCV-009-LRG LOT M20A1036) AND A BOSTON SCIENTIFIC DEFIBRILLATOR (MODEL / LOT # UNKNOWN), HAD HIS DEFIBRILLATOR DEVICE REPAIRED ON (B)(6) 2020 DUE TO A DISCOLORATION OF SKIN OVER [DEFIBRILLATOR] DEVICE HEADER IN POCKET. THERE WAS A SMALL DOT OF DARKENING SKIN OVER [DEFIBRILLATOR] HEADER. SAMPLES WERE SENT TO PATHOLOGY. AZIYO CANGAROO ENVELOPE REMAINS IMPLANTED. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS BY BOSTON SCIENTIFIC ON (B)(6) 2020.

  Patient problems: Skin Discoloration

  MAUDE report 10177263 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S ELECTRONIC SYSTEM WAS EXPLANTED DUE TO INFECTION. HOWEVER, THE AZIYO CANGAROO ENVELOPE PRODUCT REMAINS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 10016387 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9734531 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. REPORTEDLY, THE PATIENT HAD AN OPEN SUTURE LINE LEADING TO INFECTION WITH HEMATOMA. THE POCKET WAS IRRIGATED WITH ANTIBIOTIC SOLUTION AFTER REMOVAL OF THE DEVICE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

  Patient problems: Hematoma; Pocket Erosion; Unspecified Infection

  MAUDE report 9734515 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9726533 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE WAS PART OF SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS STILL IN SERVICE

  Patient problems: Unspecified Infection

  MAUDE report 9726524 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE EXPLANT DUE TO INFECTION WITH SEPSIS.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9681978 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D AND CANGAROO ENVELOPE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9681415 ↗
• InjuryApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS DISCOVERED DURING A GENERATOR CHANGE OUT ON (B)(6) 2018 SWELLING AT THE POCKET, REDNESS, AND A HEMATOMA WAS OBSERVED. IMPLANT DATE WAS (B)(6) 2018. A HEMATOMA WAS EVACUATED FROM THE POCKET AND FROM THAT RAPID CULTURES WERE NEGATIVE AND 48 HOUR CULTURE FROM SAME FLUID ALSO NEGATIVE. THE HYDRATION SOLUTION AND TIME IS UNKNOWN, BUT HAS BEEN REQUESTED (ONLY STATED "NO VANCOMYCIN" USED). IT WAS STATED THAT ARISTA, THE HEMOSTATIC AGENT, WAS USED IN THE POCKET. NO PRODUCT WAS EXPLANTED. IT WAS NOT NOTED IF THE EVENT IS RELATED TO THE DEVICE OR THE PROCEDURE.

  Patient problems: Hematoma

  MAUDE report 7396767 ↗
• InjuryOct 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT IS A (B)(6) OLD MALE WHO HAD A BIOTRONIK ICD IMPLANTED ON (B)(6) 2017 WITH KANGAROO ECM THAT WAS HYDRATED IN VANCOMYCIN. THE PATIENT RECEIVED IV ANTIBIOTICS PRIOR TO PROCEDURE. PER THE SITE, THE SUBJECT LOOKED GOOD AT WOUND CHECK AND 4-6 WEEK VISIT. ON (B)(6) 2017 THE PATIENT PRESENTED TO THE HOSPITAL (13 ½ WEEKS POST PLACEMENT) WITH NAUSEA AND FEVER. THE PATIENT WAS FOUND TO HAVE AN INFECTION AT ICD SITE. THE ACTION TAKEN WAS ICD REMOVAL. THE SITE STATES THAT THE EVENT IS NOT RELATED TO THE PROCEDURE AND PROBABLY RELATED TO THE DEVICE. A PROBABLE CAUSE FOR THE EVENT IS NOT LISTED.

  Patient problems: Unspecified Infection

  MAUDE report 6941388 ↗