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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR); PACEMAKER DATA TRANSMITTER
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR); PACEMAKER DATA TRANSMITTER Back to Search Results
Model Number EX1150
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Shock (2072)
Event Date 11/15/2018
Event Type  Injury  
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 the patient was shocked.The source of the shock was unknown.The patient did not follow up with the physician.No further information was available.
 
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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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8117647
MDR Text Key128854043
Report Number2017865-2018-18059
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberEX1150
Device Catalogue NumberEX1150
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
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