MAUDE Adverse Event Report: SANMINA SCI CORPORATION WARMTOUCH; SYSTEM, THERMAL REGULATING

Model Number	5016000
Medical Device Problem Codes	Device Alarm System (1012); High Readings (2459); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	05/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, the unit was reaching around 55°c despite being set to 40°c.The system did not display any error or warning, which resulted in burns to the patient.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: g2, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.A comprehensive examination could not be performed because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that the unit was reaching around 55°c despite being set to 40°c and the system did not display any error or warning.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: WARMTOUCH
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SANMINA SCI CORPORATION; 202 lorong perusahaan maju 9; penang 13600 ; MY 13600
• Manufacturer (Section G): SANMINA SCI CORPORATION; 202 lorong perusahaan maju 9; penang 13600 ; MY 13600
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22355264
• Report Number: 2936999-2025-00360
• Device Sequence Number: 8759364
• Product Code: DWJ
• UDI-Device Identifier: 10884521141100
• UDI-Public: (01)10884521141100(11)220504(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5016000
• Device Catalogue Number: 5016000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 05/04/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown