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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 Problem Telemetry Discrepancy (1629)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2014
Event Type  malfunction  
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.
 
Event Description
It was reported that the patient was seen in clinic and the pulse generator exhibited a telemetry anomaly.No further issues were noted during clinic visit.The patient was in good condition.
 
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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 Key4392802
MDR Text Key19374907
Report Number2017865-2015-01725
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPM2260
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/23/2014
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
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