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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PROGRAMMER; PACEMAKER PROGRAMMER
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PROGRAMMER; PACEMAKER PROGRAMMER Back to Search Results
Model Number 3650
Device Problem Incorrect Measurement (1383)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2017
Event Type  malfunction  
Event Description
It was reported that an erroneous battery longevity estimate was observed during device interrogation.Interrogation was again performed and it was concluded that the most recent estimate was accurate.No intervention was performed at this time.Patient monitoring will continue.
 
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Brand Name
MERLIN PROGRAMMER
Type of Device
PACEMAKER PROGRAMMER
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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7149719
MDR Text Key95904874
Report Number2017865-2017-36693
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3650
Device Catalogue Number3650
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2010
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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