MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. UNK_PATIENT RETURN ELECTRODES - REUSABLE; E-Z CLEAN BAYONET NEEDLE 6 INCH

Catalog Number UNK_PATIENT RETURN ELECTRODES

Device Problem Unintended Electrical Shock (4018)

Patient Problems Tachycardia (2095); Electric Shock (2554)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2021; captured as citation date.(b)(4).Additional information: from mso: electrical shock indicates injury to the body from direct contact with a high-voltage source.Electrical shock from medical devices usually induce involuntary muscle movement but rare, life-threatening symptoms could occur, including severe burns, muscle pain and contractions, seizures, and unconsciousness.Please add "organ failure" for pc's to capture organ (cardiac) dysfunction.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please confirm if the events of electromagnetic interference (emi) noted in the cadaver models needs to be included in the article review as it was only part of an experimental study of the authors in the article.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via journal article: title: inappropriate implantable cardioverter defibrillator therapy with the use of an underbody electrosurgery dispersive electrode authors: matthew j.Singleton md, mbe, mhs, msc; rohesh j.Fernando md, fase; prashant bhave md, fhrs; jerry r.Clark, md, fasa, fase; james e.Johnson phd; s.Patrick whalen md, fhrs; roger l.Royster md, facc citation: doi: https://doi.Org/10.1053/j.Jvca.2021.02.031.Perioperative management of implantable cardioverter-defibrillators is an important part of anesthetic care.Implantable cardioverter-defibrillator antitachycardia therapy may not need to be deactivated for infraumbilical surgery because electromagnetic interference is unlikely to occur.The authors presented two cases in which inappropriate antitachycardia therapy occurred intraoperatively with use of an underbody dispersive electrode, even though both surgeries were infraumbilical.In case 1, an (b)(6)-year-old man with a history of a primary prevention of implantable cardioverter defibrillators (icd) for ischemic cardiomyopathy presented with 20% total body surface area burns of his bilateral lower extremities after his clothes caught on fire while burning brush.The patient was scheduled for excision of full-thickness burns and allograft placement.During the surgery, monopolar electrosurgery was used with a dispersive return electrode (megadyne; ethicon) under the torso with the patient in the supine position.Intraoperatively, inappropriate icd discharge was noted.Post-operative interrogation noted 18 episodes of electromagnetic interference (emi) that were detected as ventricular arrhythmias over a 29-minute period resulting in the delivery of two episodes of inappropriate antitachycardia pacing and seven inappropriate shocks.In case 2, a (b)(6)-year-old man with a history of primary prevention single-chamber icd for subsequently-recovered non-ischemic cardiomyopathy.The patient was presented for elective repair of a chronic displaced subtrochanteric fracture of the right femur with non-union.On the day of surgery, the patient was placed in the supine position, and monopolar electrosurgery (megadyne; ethicon) was used with an underbody dispersive return electrode.Subsequent remote transmission from his icd revealed emi with three rounds of antitachycardia pacing and three shocks.An inappropriate defibrillation from an icd is potentially a serious event.Although the patients were anesthetized and did not feel pain as a result of the icd discharging, ventricular fibrillation, myocardial injury, and a reduction in the device battery life can occur.In particular, the use of a dispersive electrode such as the megadyne (ethicon) likely significantly increases the risk of emi.Overall, the authors believe the management of icds in the presence of electrosurgery is more complex than the location of electrosurgery relative to the umbilicus.

Manufacturer Narrative

(b)(4), date sent: 3/23/2021 h6 and h10: procedural complications (e21).Additional information from mso: i would much prefer cardiac dysfunction in this case but we are limited by what we have in the list.While it is true that ¿organ failure is the closest one¿, it does not fit well with case description.I think that we should remove it because of inaccuracy if no other choice.

Manufacturer Narrative

(b)(4).Date sent: 1/4/2024.Additional information received: change impacted product code for ¿old¿ (b)(4).From ¿unk_e-z clean non-stick electrosurgical electrodes¿ to ¿unk_patient return electrodes ¿ reusable¿ or ¿0846.¿ there is a picture of the 0846 in the article for patient 1.Unclear which underbody dispersive electrode was used in patient 2.There is reference to the megadyne 0039h pencil in the first cadaver experiment, but it was just used as part of the experiment on the reusable return electrodes, so i don¿t think we need to reference the ez clean pencil in the complaint.D1, d4.

• Brand Name: UNK_PATIENT RETURN ELECTRODES - REUSABLE
• Type of Device: E-Z CLEAN BAYONET NEEDLE 6 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kara ditty-bovard ; 11506 south state street; draper, UT 84020 ; 6107428552
• MDR Report Key: 11453593
• MDR Text Key: 245078821
• Report Number: 1721194-2021-00022
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K081791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PATIENT RETURN ELECTRODES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention