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

Model Number	5034
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	02/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Allergan received provider report that on (b)(6) 2020 a patient was being treated with cooltone and the device shut down mid treatment.The treatment provider experienced an electric shock when they attempted to power the machine back on.The treatment provider then attempted to unplug the device and experienced an electric shock up their arm.
Additional Manufacturer Narrative
Additional information: on july 07, 2020, allergan received additional information from the treatment provider.The treatment provider reported that the electric shock that was previously reported was so strong it make her stumble back a few steps.She reported her right arm was aching for approximately one week following the event.She also reported that she was wearing metallic nail polish and the shock removed the polish off of her right hand.She reported that the treatment room has wood flooring and there was no rug or mat placed between the floor and the device or treatment bed.Correction to a3 and d10.

• Brand Name: COOLTONE
• Common Device Name: STIMULATOR, MUSCLE, POWERED FOR MUSCLE CONDITIONING
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm, 98231 ; GM 98231
• MDR Report Key: 9918533
• Report Number: 3007215625-2020-30001
• Device Sequence Number: 16768387
• Product Code: NGX
• UDI-Device Identifier: 04053815076698
• UDI-Public: (01)04053815076698(11)200212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020
• Report Date (Section F): 04/02/2020

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
• Operator of Device: Health Professional
• Device Model Number: 5034
• Device Catalogue Number: CS-MS-002-D-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/07/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 04/02/2020