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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 Problems Charred (1086); Power Conditioning Problem (1474)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient house was hit by lightening and the cardiac transmitter would not power up.The device was unplugged from the outlet and the prongs removed.Visible charring was seen.A different outlet was attempted but the device did not power up.The transmitter was exchanged.
 
Manufacturer Narrative
The damage was found sustained in the field.The device was otherwise normal.
 
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Brand Name
MERLIN@HOME, RF TELEMETRY BASIC
Type of Device
PACEMAKER DATA TRANSMITTER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6070560
MDR Text Key58928474
Report Number2017865-2016-06901
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 consumer
Type of Report Initial,Followup,Followup
Report Date 08/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEX1150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2016
Date Manufacturer Received08/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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