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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ASSURITY RF DR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ASSURITY RF DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2240
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802)
Event Date 08/27/2018
Event Type  Death  
Event Description
It was reported that the patient expired.The cause of death was cardiorespiratory failure.There is no known allegation from a health professional that suggests the death was related to the device.No additional information is available.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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Brand Name
ASSURITY RF DR
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7937148
MDR Text Key122785103
Report Number2938836-2018-11128
Device Sequence Number1
Product Code LWP
UDI-Device Identifier05414734507073
UDI-Public05414734507073
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2017
Device Model NumberPM2240
Device Lot NumberA000021232
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2018
Was the Report Sent to FDA? No
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
1888TC/46, (B)(4); 1888TC/52, (B)(4)
Patient Outcome(s) Death;
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