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

Model Number	5034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No additional information was received regarding any treatment or medical intervention required for the reported event.A supplemental report will be submitted if additional information is obtained.Reporting delayed due to computer problems.
Event or Problem Description
Allergan aesthetics received a report from a patient who received cooltone treatment in (b)(6) 2024, and had severe pain in the right thigh and stopped treatment.Reporter indicated that the patient went to see a sports medicine doctor and was diagnosed with tendon tear from bone.It was reported that the patient lost all the muscle in the thighs and buttocks because of this.Though requested, additional event information was not provided by the patient.Zimmer medizinsysteme gmbh was informed by allerganaesthetics on this event.

• Brand Name: COOLTONE
• Common Device Name: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING, PRODUCT CODE: NGX
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm, bavaria 89231 ; GM 89231
• Manufacturer (Section G): ZIMMER MEDIZINSYSTEME GMBH; leibnizstrasse 9; neu-ulm, bavaria 89231 ; GM 89231
• Manufacturer Contact: stefan leinweber ; junkersstrasse 9; neu-ulm, bavaria 89231 ; GM 89231
• MDR Report Key: 23378729
• Report Number: 8010720-2025-01774
• Device Sequence Number: 8824437
• Product Code: NGX
• UDI-Device Identifier: 04053815076698
• UDI-Public: 04053815076698
• Combination Product (Y/N): N
• PMA/510(K) Number: K251378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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
• Device Lot Number: N/A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown