MAUDE Adverse Event Report: ZIMMER MEDIZINSYSTEME GMBH EMFIELDPRO; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Catalog Number 5032

Device Problems Failure to Conduct (1114); Corroded (1131); Electromagnetic Interference (1194)

Patient Problems Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Electro-Mechanical Dissociation (1826)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

There is no direct causal relationship between the emfieldpro device and the patient¿s hospitalization and surgery.However, a contributory relationship between the emfieldpro device and the pacemaker malfunction cannot be ruled out due to electromagnetic interference.In addition the possibility of the emfieldpro device interfering with the external resulting in the transmission of abnormal data cannot be ruled out.This event was assessed as reportable, related to the emfieldpro device and serious due to the surgical procedure that was done on the patient, and recurrence in a similar situation may lead to serious injury.Allergan made several attempts to obtain the current status of the staff member in report, clarification on provided dates and other case details but no update has been received to date.Allergan will continue to seek additional information.A supplemental report will be submitted if additional information is obtained.

Event Description

Allergan received report from a treatment provider regarding a female staff member, approximately (b)(6) whose pacemaker stopped working two days after several emfieldpro treatments were performed in the clinic.The nursing director reported that the staff member was in a different room, approximately 15 feet away from the emfieldpro treatment room, and there had been no direct or close contact between the emfieldpro device and the staff member in report.The nursing director also reported that prior to the emfieldpro treatments being performed in the clinic the staff member already had pre-existing issues with her 7 year-old pacemaker having corroded leads, causing her to wear an external monitor which relayed information to her attending physician.Two days after the emfieldpro treatments, the staff member¿s physician advised her to go to the hospital to have her pacemaker changed as abnormalities were detected by the monitor.The staff member went on medical leave and was hospitalized requiring surgical intervention.

• Brand Name: EMFIELDPRO
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm
• Manufacturer (Section G): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm
• Manufacturer Contact: jennifer cleto ; 4410 rosewood drive; pleasanton, CA 94588 ; 9256214130
• MDR Report Key: 9380230
• MDR Text Key: 168430024
• Report Number: 8010720-2019-00001
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• PMA/PMN Number: K182963
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention