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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD ASSURITY PLUS DR RF; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC., CRMD ASSURITY PLUS DR RF; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2260
Device Problems Difficult to Interrogate (1331); Telemetry Discrepancy (1629)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2014
Event Type  malfunction  
Event Description
It was reported that during the implant procedure, the pulse generator could not be interrogated using radiofrequency telemetry.The device was successfully interrogated using inductive telemetry.The device remained implanted.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.
 
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Brand Name
ASSURITY PLUS 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 Key4069400
MDR Text Key17571186
Report Number2017865-2014-15916
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeSE
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2015
Device Model NumberPM2260
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2014
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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