Neo Legacy 2100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00859144004210), received between Jun 14, 2016 and Aug 14, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2024Unintended Movement; Unintended Movement

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022.THE PATIENT REPORTED THAT FOLLOWING WEIGHT LOSS, THEY HAVE ACCUMULATED LOOSE SKIN FROM THE BREAK-DOWN OF FAT AROUND THE IPG POCKET. THE PATIENT WAS NOTICING THE IPG MOVE WHEN PERFORMING ACTIVITIES SUCH AS BENDING DOWN, CHANGING ELEVATION LEVEL AND WHILE LAYING DOWN TO SLEEP. THE PATIENT FELT THE IPG WAS MOVING UP TO 180 DEGREES. THE PATIENT WAS ADVISED TO CONTACT THEIR CARE TEAM. A POCKET REVISION WAS APPROVED AND WAS SUCCESSFULLY PERFORMED ON (B)(6) 2024. THE IPG WAS PLACED IN AN ANTIBACTERIAL POUCH AND ANCHORED TO THE FASCIA. AS OF (B)(6) 2024, THE PATIENT REPORTED THAT THEY WERE DOING GREAT.

  Patient problems: Pocket Erosion

  MAUDE report 19986512 ↗
• InjuryApr 12, 2023Unintended Movement; Unintended Movement

  A NORMAL IPG REPLACEMENT OCCURRED ON (B)(6) 2022. THE PATIENT EXPERIENCED THE IPG SHIFTING FROM SIDE TO SIDE, AND STATED IT WAS NEVER COMFORTABLE SINCE IMPLANT. A SMALL OPENING WAS OBSERVED A WEEK OR TWO PRIOR TO (B)(6) 2023, BUT THERE WERE NO SIGNS OF INFECTION. IN THE OPINION OF THE PHYSICIAN, THE ISSUE WAS RELATED TO THE PATIENT'S LOW WEIGHT AND BREAST IMPLANTS NOT LEAVING ENOUGH TISSUE TO PROTECT THE DEVICE, AND THE NUMBER OF REPLACEMENTS WAS A POSSIBLE CONTRIBUTING FACTOR. A POCKET REVISION OCCURRED ON (B)(6) 2023. THE IPG WAS PLACED SUBMUSCULARLY, AND THE PROCEDURE WENT WELL. AS OF (B)(6) 2023, THE PATIENT'S WOUND WAS HEALED AND THERE WERE NO FURTHER CONCERNS.

  Patient problems: Discomfort; Wound Dehiscence

  MAUDE report 16725132 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A IPG REPLACEMENT ON (B)(6) 2021. ON (B)(6) 2022, IT WAS REPORTED THAT THAT THE PATIENT EXPERIENCED AN INFECTION AT THE DEVICE POCKET. THE CAUSE OF THE INFECTION WAS NOT ABLE TO BE PROVIDED. THE IPG WAS EXPLANTED ON (B)(6) 2022. THE POCKET WAS CLEANED, AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 13527969 ↗
• InjuryMar 28, 2019High impedance; High impedance

  AT A POST IPG REPLACEMENT FOLLOW-UP ON 15-JAN-2019, THE LEAD IMPEDANCE OF THE SYSTEM VARIED BETWEEN 1200 AND 1700 OHMS. IT HAD BEEN NORMAL AT APPROXIMATELY 600 OHMS AT THE TIME OF IPG REPLACEMENT ON 05-DEC-2018. DOCTOR CHOSE TO LEAVE THERAPY ON AND HAVE PATIENT RETURN TO CHECK IN ONE MONTH. REPORTED ON (B)(6) 2019 THAT THE PATIENT STATED BLOOD PRESSURE OF 170S SYSTOLIC AND 100-120 DIASTOLIC AND NOT IN CONTROL AND THAT THE PATIENT WOULD LIKE TO DO A LEAD REPAIR. (B)(6), CVRX SR. DIRECTOR OF LEADS DEVELOPMENT AND OPERATIONS, ATTENDED THE SURGERY ON (B)(6) 2019. THIS IS WHERE THE EVENT BECAME REPORTABLE. IN REVIEWING THE SITUATION IN SURGERY, IT WAS NOTED THAT THERE WAS CONTAMINATION ON THE LEAD TERMINAL PIN THAT WAS THE CAUSE OF THE HIGH IMPEDANCE. NO REPAIR WAS REQUIRED; HOWEVER, THE LEAD TERMINAL PIN COULD NOT BE WIPED CLEAN AND REQUIRED SCRAPING WITH A SCALPEL TO REMOVE THE CONTAMINATION. THE IPG WAS REPLACED AS THERE WAS ALSO EVIDENCE OF CONTAMINATION IN THE HEADER BORE. IT WAS UNCLEAR IF THE CONTAMINATION WAS A BODILY FLUID THAT HAD DRIED ON THE SURFACE OR IF IT WAS POTENTIALLY CORROSION OF THE METALS. THE IPG WAS RETURNED TO CVRX FOR ANALYSIS. IT WAS ALSO REPORTED THAT THE SURG

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 8462137 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON APPROXIMATELY (B)(6) 2018, THE PATIENT SPOKE WITH (B)(6) AT (B)(6) HEART AND COMPLAINED OF PAIN, THOUGHT THE DEVICE HAD MOVED, AND WANTED TO BE SEEN. THE PATIENT IS TYPICALLY SEEN IN (B)(6), BUT LIVES IN (B)(6), SO A FOLLOW-UP WAS SCHEDULED AT (B)(6). ON (B)(6) 2018, THE PATIENT WAS SEEN AND WAS EXPERIENCING REDNESS, SKIN EROSION, POSSIBLE INFECTION, PAIN, SWELLING AT THE POCKET. A REPLACEMENT WAS SCHEDULED FOR (B)(6) 2018. ON (B)(46) 2018, THE SKIN HAD BEEN FOUND TO BE ERODED, AND THE IPG WAS EXPLANTED. THE POCKET WAS CULTURED AND PACKED WITH IODOFORM GAUZE. THE PATIENT HAS A FOLLOW-UP APPOINTMENT ON (B)(6) 2018. THIS EVENT BECAME REPORTABLE ON (B)(6) 2018.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 7327569 ↗
• InjuryDec 20, 2017Fracture; Fracture

  A DOUBLE LEAD REPAIR WAS DONE AT (B)(6) ON (B)(6) 2017 DURING A NORMAL IPG REPLACEMENT. IPG (B)(4) WAS REPLACED WITH (B)(4). THE RIGHT LEAD WAS SEVERED, AND THE TERMINAL PIN WAS MISSING SO THAT LEAD WAS FIXED FIRST. DR. (B)(6) SUCCESSFULLY REPAIRED THE LEAD RESULTING IN AN IMPEDANCE OF 349. NEO LEAD REPAIR KIT (B)(4) WAS USED TO REPAIR THE RIGHT LEAD. THE OUTER COIL ON THE LEFT LEAD WAS STRETCHED OUT BETWEEN THE TERMINAL PIN AND TUBING AROUND THE LEAD SERIAL NUMBER LABEL, BUT IT STILL SHOWED GOOD CONNECTIVITY WITH AN IMPEDANCE OF 377. TO REINFORCE THIS SECTION OF THE LEAD, DR. (B)(6) PUT A TUBE AROUND THIS PORTION AND FILLED IT WITH SILICONE ADHESIVE. THE FINAL IMPEDANCE FOR THE LEFT LEAD WAS 376. THE PATIENT HAD NOT BEEN EXPERIENCING ANY SYMPTOMS LEADING UP TO THE IPG REPLACEMENT AND LEAD REPAIRS.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7134425 ↗
• InjuryJun 14, 2016Migration or Expulsion of Device

  PATIENT COMPLAINED OF PAIN AND BRUISING ON (B)(6) 2016 DUE TO DEVICE MOVING OUT OF THE POCKET. THE LAST IPG REPLACEMENT SURGERY TOOK PLACE ON (B)(6) 2015 AT (B)(6). PHOTOS AND X-RAYS SENT ON (B)(6) 2016 SHOWED THAT THE IPG HAD SHIFTED IN THE POCKET AND THE LEDS WERE INTERTWINED BUT DID NOT APPEAR TO BE DAMAGED.

  Patient problems: Twiddlers Syndrome

  MAUDE report 5723532 ↗