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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 Device Operates Differently Than Expected (2913)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 05/20/2017
Event Type  Injury  
Event Description

It was reported that during implant, the implantable cardiac defibrillator pacing function could not be switched on due to merlin touchscreen anomaly. The patient became asystolic. The patient was resuscitated via cpr. A different programmer was used. Patient was intubated on the cath lab table and was extubated the next day. No further information was reported.

 
Manufacturer Narrative

The field complaint of intermittent functionality was verified. During analysis, the programmer would sometimes be unresponsive or display error message. The system as a whole was freezing up. The software was corrupt. Re-loading software restored normal functions.

 
Manufacturer Narrative

Correction: the returned information was not previously selected.

 
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Brand NameMERLIN PROGRAMMER
Type of DevicePACEMAKER 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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6675702
MDR Text Key78651495
Report Number2017865-2017-04218
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3650
OTHER Device ID Number05414734500661
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/22/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/27/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/28/2017 Patient Sequence Number: 1
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