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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 EX1150
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2017
Event Type  malfunction  
Manufacturer Narrative
No conclusion code available. Failure event observed during analysis. Final analysis found burnt components on the main circuit board of the ac power adapter and on the main circuit board of the transmitter. A burn mark on the inner casing of the ac adapter was also noted. It was concluded that the damage sustained occurred after exposure to a high current flow from the power outlet.
 
Event Description
This report is to advise of an event observed during analysis.
 
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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 Key6822635
MDR Text Key83727028
Report Number2017865-2017-08079
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 08/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberEX1150
Other Device ID Number05414734504799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2017
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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