MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) USB CELLULAR ADAPTER; ACCESSORY

Model Number	EX1151
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Further information was requested but not received.
Event or Problem Description
Related manufacturer reference number: 2017865-2019-18569.It was reported that during a scheduled data transmission, the merlin transmitter usb port and usb cellular adapter were suspected to have been melted due to head caused by longtime use.The devices were replaced.No adverse patient consequences were reported.
Additional Manufacturer Narrative
The field complaint of the transmitter's usb port and the usb maybe being melted was not verified.Analysis was normal.No anomalies were found.

• Brand Name: USB CELLULAR ADAPTER
• Common Device Name: ACCESSORY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9527813
• Report Number: 2017865-2019-18570
• Device Sequence Number: 11422632
• Product Code: NVZ
• UDI-Device Identifier: 05414734507011
• UDI-Public: 05414734507011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2020

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: EX1151
• Device Catalogue Number: EX1151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/08/2020; 01/28/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 01/12/2020; 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR