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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PACEMAKER DATA TRANSMITTER Back to Search Results
Model Number EX1150
Device Problem Wireless Communication Problem (3283)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 09/12/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the device was not transmitting through the remote transmission. The patient was not feeling well and presented in the emergency room. The device delivered alerts for ventricular tachycardia and ventricular fibrillation episodes and they were successfully treated with atp and hv therapy. The patient was discharged and was doing fine after the event.
 
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Type of DevicePACEMAKER DATA TRANSMITTER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jaime chavez
645 almanor avenue
sunnyvale, CA 94085
8184934022
MDR Report Key6032716
MDR Text Key57551085
Report Number2938836-2016-12799
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 company representative,consum
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 09/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEX1150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2016
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 Treatment Data
Date Received: 10/16/2016 Patient Sequence Number: 1
Treatment
CD1411-36Q, 7137098
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