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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD ASSURITY DR RF; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC., CRMD ASSURITY DR RF; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2240
Device Problems Telemetry Discrepancy (1629); Out-Of-Box Failure (2311)
Patient Problem No Patient Involvement (2645)
Event Date 03/19/2015
Event Type  malfunction  
Event Description
It was reported that the pulse generator exhibited a telemetry radiofrequency anomaly when interrogated in the box.The device was not implanted.
 
Manufacturer Narrative
(b)(4).Final analysis of the pulse generator found that radiofrequency was terminated, as received.After a product code download, radiofrequency was enabled and normal function resumed.The cause of the rf termination could not be determined.(b)(6).
 
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Brand Name
ASSURITY DR RF
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jennie hamel
15900 valley view court
sylmar, CA 91342
8184933462
MDR Report Key4754204
MDR Text Key19309484
Report Number2017865-2015-05066
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2016
Device Model NumberPM2240
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/19/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2015
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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