CHATTANOOGA 2761Recalls & reported problems
Djo, LLC · VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL · Class 2
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912292849), received between Dec 12, 2017 and Apr 30, 2025 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Electrical /Electronic Property Problem1
- Electrical Overstress1
- Intermittent Energy Output1
- Unintended Electrical Shock1
Patient problems
- Partial thickness (Second Degree) Burn3
- Burn(s)2
- Full thickness (Third Degree) Burn2
- Electric Shock1
- Lead(s), Burn(s) From1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT SUSTAINED 5 BURNS WHERE ELECTRODES WERE PLACES DURING TREATMENT THAT WERE TREATED TOPICALLY BY WOUND CARE USING STANDARD BURN CREAM AND INFECTION TREATMENTS.
Patient problems: Burn(s); Unspecified Infection
MAUDE report 21940269 ↗InjuryDec 21, 2022Unintended Electrical Shock; Unintended Electrical Shock
IT WAS REPORTED THAT THE UNIT ALLEGEDLY SHOCKED AND CAUSED A BURN TO PATIENT DURING TREATMENT.
Patient problems: Burn(s); Electric Shock
MAUDE report 16026891 ↗InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A SECOND DEGREE BURN FROM TREATMENT.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 12628361 ↗MalfunctionDec 23, 2019Intermittent Energy Output; Intermittent Energy Output
IT WAS REPORTED THAT THE "INTENSITY INTERMITTENTLY SURGES" DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9510522 ↗InjuryAug 5, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT "THE UNIT WAS ORIGINALLY SET AT 44 BUT ABOUT 8 MINUTES IN GAVE AN OVERCURRENT ERROR & THE UNIT STOPPED WORKING-THE SET AT 35 AND CONTINUED TREATMENT WHEN FINISHED THE PATIENT HAD A BURN AND BLISTER". [SIC] NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 8860883 ↗InjuryApr 11, 2019Electrical Overstress; Electrical Overstress
IT WAS REPORTED THAT THE PATIENT RECEIVED A SMALL 2CM X 0.8CM BURN UNDER AN ELECTRODE. THE PATIENT WAS BEING TREATED FOR ACUTE BACK PAIN USING INTERFERENTIAL CURRENT (IFC) WITH CONSTANT VOLTAGE (CV). NURSING WAS IMMEDIATELY NOTIFIED, FOLLOWED BY A PHYSICIAN. THE WOUND WAS CLEANSED BY NURSING, SILVADENE WAS APPLIED, AND THE WOUND WAS COVERED BY A NON-STICK GAUZE, CHANGED TWICE A DAY. THE PATIENT WAS MONITORED AT A SKILLED NURSING FACILITY FOR SIGNS AND SYMPTOMS OF INFECTION. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Full thickness (Third Degree) Burn; Lead(s), Burn(s) From
MAUDE report 8503356 ↗InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT RECEIVED THAT ALLEGES "DURING AN INTERFERENTIAL E-STEM TREATMENT FOR A MUSCLE SPASM ON CHANNEL 2 AND 3 A PATIENT RECEIVED A BURN UNDER TWO ELECTRODE PADS. THE PATIENT WAS INSTRUCTED THAT THE INTENSITY SHOULD BE STRONG BUT NOT PAINFUL, AND THEY NEEDED TO INDICATE WHEN THE INTENSITY WAS SUFFICIENT FOR THEM, WHICH HE DID SO. ABOUT 2-3 MINUTES INTO THE 12 MINUTE TREATMENT HE ASKED FOR IT TO BE TURNED DOWN, WHICH IT WAS UNTIL HE INDICATED IT WAS A BETTER INTENSITY. ABOUT 3-4 MINUTES LATER HE AGAIN ASKED FOR IT TO BE TURNED DOWN, WHICH AGAIN IT WAS UNTIL HE INDICATED IT WAS BETTER. AFTER ABOUT A MINUTE HE COMPLAINED OF IT FEELING HOT/ BURNING DESPITE NOT HAVING ANY HEAT PACKS OR ICE ASSOCIATED WITH THE TREATMENT. HE WAS TOLD THAT WAS NOT NORMAL, AND HE HAD THE CHOICE TO CONTINUE WITH THE TREATMENT AND KEEP TURNING IT DOWN, OR THAT HE COULD TERMINATE THE TREATMENT. HE CHOSE TO TURN IT DOWN AGAIN, AND AFTER ABOUT 1 MINUTE ASKED FOR IT TO BE TURNED OFF. THERE WAS ABOUT 2 MINUTES LEFT ON THE TREATMENT. THE TREATMENT WAS GIVEN UNDER HIS SHIRT TO HIS RHOMBOID, THE LEADS WERE REMOVED AND HE WENT TO THE LOCKER ROOM. HE RETURNED TO SHOW ME HIS BURNS, AND HIS WOUNDS WERE CLEANED, TREATED
Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn
MAUDE report 7109689 ↗
Other STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL devices
- MyoCycle MC-2Myolyn, LLC · Stimulator, Neuromuscular, External Functional2 reports
- CIONIC NS-100Cionic, Inc. · Stimulator, Neuromuscular, External Functional1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.