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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) MERLIN PROGRAMMER PACEMAKER PROGRAMMER

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) MERLIN PROGRAMMER PACEMAKER PROGRAMMER Back to Search Results
Model Number 3650
Device Problem Failure to Read Input Signal (1581)
Patient Problems Syncope (1610); Cardiac Arrest (1762); Seizures (2063)
Event Date 10/05/2018
Event Type  Malfunction  
Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.

 
Event Description

It was reported that during threshold testing of the left ventricular lead, the programmer continued to decrease the lead voltage after the tester removed their finger from the screen. The pacing-dependent patient went into asystole, lost consciousness, and began to seize. The device started pacing again after a period of asystole. The patient is recovering.

 
Manufacturer Narrative

The reported field event of touch input failure could not be verified. Both the "hold to test" and vvi buttons were tested and functioned without issue. The programmer was tested on the bench and excessive amounts of hard disk drive errors were detected. Hdd errors can sometimes interfere with the programmer's response time.

 
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Brand NameMERLIN PROGRAMMER
Type of DevicePACEMAKER PROGRAMMER
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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7967260
MDR Text Key123799658
Report Number2938836-2018-11385
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/15/2018
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? Device Returned To Manufacturer
Date Returned to Manufacturer10/29/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/14/2018
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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