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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC MERLIN@HOME, RF TELEMETRY BASIC PACEMAKER DATA TRANSMITTER

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ST. JUDE MEDICAL, INC MERLIN@HOME, RF TELEMETRY BASIC PACEMAKER DATA TRANSMITTER Back to Search Results
Model Number EX1150
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The results of the analysis confirmed the reported event of (failure to start up). After opening the ac power adapter burnt components were observed on the main circuit board. A burned mark on the inner casing of the ac power adapter was noticed. Upon opening the transmitter, no damages were observed on the main pcb. As a result, we can conclude that the root-cause of the failure to start up issue was the burnt damage that the ac power adapter's main pcb sustained through the ac electrical power outlet.
 
Event Description
This report is to advise of an event observed during analysis. After opening the ac power adapter burnt components were observed on the main circuit board. A burned mark on the inner casing of the ac power adapter was noticed. There were no reported adverse patient consequences related to the event.
 
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Brand NameMERLIN@HOME, RF TELEMETRY BASIC
Type of DevicePACEMAKER DATA TRANSMITTER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7465386
MDR Text Key106649777
Report Number2017865-2018-05934
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Patient
Type of Report Initial
Report Date 04/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEX1150
Device Catalogue NumberEX1150
Other Device ID Number05414734504799
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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