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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN@HOME, RF TELEMETRY BASIC PACEMAKER DATA TRANSMITTER Back to Search Results
Model Number EX1150C
Device Problem Melted (1385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2017
Event Type  malfunction  
Manufacturer Narrative
No conclusion code available. The field complaint of the transmitter¿s power cable being melted was not verified but black liquid on the power cable was verified. The unit was plugged into a working ac electrical outlet and powered on successfully.
 
Event Description
It was reported that a part of the power cable of the merlin transmitter was melted and there was black liquid stuck to the cable. There were no adverse consequences to the patient. The device was replaced.
 
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Brand NameMERLIN@HOME, RF TELEMETRY BASIC
Type of DevicePACEMAKER DATA TRANSMITTER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6909267
MDR Text Key114365419
Report Number2017865-2017-32652
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 06/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEX1150C
Other Device ID Number05414734404334
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2014
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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