UNK_PATIENT RETURN ELECTRODES - REUSABLE
Report
- Report Number
- 1721194-2019-00123
- Event Type
- Injury
- Date Received
- October 8, 2019
- Report Date
- September 9, 2019
- Manufacturer
- MEGADYNE MEDICAL PRODUCTS, INC.
- Product Code
- GEI
- PMA / PMN Number
- K133726
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONALLY, THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.
TITLE: ELECTROMAGNETIC INTERFERENCE WITH PROTOCOLIZED ELECTROSURGERY DISPERSIVE ELECTRODE POSITIONING IN PATIENTS WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AUTHORS: PETER M. SCHULMAN, M.D.; MIRIAM M. TREGGIARI, M.D., PH.D., M.P.H.,; N. DAVID YANEZ, PH.D.; CHARLES A. HENRIKSON, M.D.; PETER M. JESSEL, M.D.; THOMAS A. DEWLAND, M.D.; MATTHIAS J. MERKEL, M.D., PH.D.; VALERIE SERA, M.D.; IZUMI HARUKUNI, M.D.; RYAN B. ANDERSON, M.D., PH.D.; ED KAHL, M.D.; ANN BINGHAM, M.D.; NABIL ALKAYED, M.D., PH.D.; ERIC C. STECKER, M.D., M.P.H. CITATION: ANESTHESIOLOGY. 2019; 130:530¿40. THE GOAL OF THE STUDY WAS TO DETERMINE THE OCCURRENCE OF INTRAOPERATIVE ELECTROMAGNETIC INTERFERENCE FROM MONOPOLAR ELECTROSURGERY IN PATIENTS WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR UNDERGOING SURGERY. A PROCTOLIZED APPROACH WAS USED TO POSITION THE DISPERSIVE ELECTRODE. THIS WAS A PROSPECTIVE COHORT STUDY INCLUDING 144 PATIENTS WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS UNDERGOING SURGERY BETWEEN MAY 2012 AND SEPTEMBER 2016 AT AN ACADEMIC MEDICAL CENTER. OF WHICH, 70 PATIENTS HAD SURGERY ABOVE THE UMBILICUS (42 MALE AND 28 FEMALE PATIENTS; AGE: 62 ± 14), 40 PATIENTS HAD SURGERY BELOW THE UMBILICUS (29 MALE AND 11 FEMALE PATIENTS; AGE: 65 ± 11), AND 34 PATIENTS HAD CARDIAC SURGERY (28 MALE AND 6 FEMALE PATIENTS; AGE: 50 ± 15). DURING THE SURGICAL PROCEDURE IN ALL GROUPS, THE MEGADYNE UNDER BODY DISPERSIVE ELECTRODE (ETHICON) WAS USED FOR PATIENTS UNDERGOING CARDIAC SURGERY. THE ELECTROSURGERY UNIT WAS UTILIZED AS CLINICALLY INDICATED WITH SETTINGS AND DURATION OF USE LEFT AT THE SURGEON¿S DISCRETION. IN SURGERY ABOVE THE UMBILICUS GROUP, REPORTED COMPLICATIONS INCLUDED OCCURRENCE OF INTRAOPERATIVE ELECTROMAGNETIC INTERFERENCE (N-14) AND SHOCK (N-2). IN SURGERY BELOW THE UMBILICUS GROUP, REPORTED COMPLICATIONS INCLUDED OCCURRENCE OF INTRAOPERATIVE ELECTROMAGNETIC INTERFERENCE (N-1), IN THE CARDIAC SURGERY GROUP, REPORTED COMPLICATIONS INCLUDED OCCURRENCE OF INTRAOPERATIVE ELECTROMAGNETIC INTERFERENCE (N-23), SHOCK (N-5), AND INTRAOPERATIVE VENTRICULAR ARRHYTHMIA (N-6). DESPITE PROTOCOLIZED DISPERSIVE ELECTRODE POSITIONING, THE RISKS OF ELECTROMAGNETIC INTERFERENCE AND CLINICALLY MEANINGFUL ELECTROMAGNETIC INTERFERENCE WITH SURGERY ABOVE THE UMBILICUS WERE HIGH, SUPPORTING PUBLISHED RECOMMENDATIONS TO SUSPEND ANTITACHYCARDIA THERAPY WHENEVER MONOPOLAR ELECTROSURGERY IS USED ABOVE THE UMBILICUS. FOR SURGERY BELOW THE UMBILICUS, THESE RISKS WERE NEGLIGIBLE, IMPLYING THAT SUSPENDING ANTITACHYCARDIA THERAPY IS LIKELY UNNECESSARY IN THESE PATIENTS. FOR CARDIAC SURGERY, THE RISKS OF ELECTROMAGNETIC INTERFERENCE AND CLINICALLY MEANINGFUL ELECTROMAGNETIC INTERFERENCE WITH AN UNDERBODY DISPERSIVE ELECTRODE WERE HIGH. CONSERVATIVE PROGRAMMING STRATEGIES WOULD NOT HAVE ELIMINATED THE RISK OF CLINICALLY MEANINGFUL ELECTROMAGNETIC INTERFERENCE IN EITHER NONCARDIAC SURGERY ABOVE THE UMBILICUS OR CARDIAC SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 959284 | UNK_PATIENT RETURN ELECTRODES - REUSABLE | MEGA SOFT PHONE CABLE 4.4M (14-4") | GEI | MEGADYNE MEDICAL PRODUCTS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |