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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 Electronic Property Issue (2928)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The reported field event of an inability to start up the transmitter was confirmed in the laboratory.The complaint was verified as the unit was plugged into the outlet and did not power on.The device was tested on the bench and the original ac power adapter was found to be defective.Inspection of the ac power adapter revealed burn marks.The unit was scrapped due to a power anomaly.
 
Event Description
The patient said the power of the transmitter was out of order with the green light off.So the transmitter needed to be repaired.
 
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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)
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 Key6526990
MDR Text Key74044064
Report Number2017865-2017-02651
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEX1150
Other Device ID Number05414734504799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/24/2017
Initial Date FDA Received04/27/2017
Supplement Dates Manufacturer Received08/01/2017
Supplement Dates FDA Received08/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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