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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 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 Date 09/06/2019
Event Type  malfunction  
Manufacturer Narrative
The merlin@home transmitter presented with a no power issue and burnt damage to the ac power adapter. The visual inspection revealed no physical damage to the outer housing of the merlin@home transmitter and no physical damage to the outer casing of the ac power adapter; however, the inspection of the green contact strips in the ac power adapter revealed burnt damage. In turn, the transmitter was not plugged into a working ac electrical outlet. Upon opening the ac power adapter, inspection revealed that there were burnt components on both sides of the main pcb and on its¿ inner casing. After opening the transmitter, inspection revealed that there were multiple burnt components on the main pcb. As a result, we can conclude that the root-cause of the no power issue was the burnt damage that the ac power adapter's main pcb and the merlin@home transmitter¿s main pcb sustained through high current flow through the ac electrical power outlet.
 
Event Description
It was reported that the unit was observed to be burned.
 
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Brand NameMERLIN@HOME, RF TELEMETRY BASIC
Type of DevicePACEMAKER DATA TRANSMITTER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key9132099
MDR Text Key160435329
Report Number2938836-2019-14138
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 company representative
Type of Report Initial
Report Date 09/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEX1150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2019
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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