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

Model Number	5034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cooltone¿ device is an electromagnetic muscle stimulation device indicated for improvement of abdominal tone and strengthening of the abdominal muscles and buttocks.The electromagnetic field induces a current of sufficient amplitude and duration to ultimately stimulate supramaximal muscle contractions.These contractions might have led to repositioning of iud.
Event or Problem Description
Abbvie received a report on 5/31/2023 ((b)(4)): a provider reported to allergan that a patient received a cooltone treatment to the abdomen on (b)(6) 2023 and presented with "strong abdominal contractions that sucked her [plastic skyla] iud up further into her uterus".The patient was in extreme pain and ended up going to the er to have it repositioned" 1 day post treatment.

• Brand Name: COOLTONE
• Common Device Name: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• 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: 21662846
• Report Number: 0008010720-2024-01701
• Device Sequence Number: 12848727
• Product Code: NGX
• UDI-Device Identifier: 04053815076698
• UDI-Public: 04053815076698
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K220601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/19/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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: Hospitalization
• Patient Age: 40 YR
• Patient Sex: Female