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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ANTHEM RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ANTHEM RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3210
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arrhythmia (1721)
Event Date 07/10/2021
Event Type  Death  
Event Description
Related manufacturer reference number: 2017865-2021-28993.Related manufacturer reference number: 2017865-2021-28994.It was reported that the patient has deceased.There is no known allegation from a health care professional that suggests the death was device related.The cause of death was cardiac arrest.No additional information was reported.
 
Manufacturer Narrative
The device was received from the field with battery voltage above elective replacement indicator (eri) level.Analysis of device image and longevity assessment testing indicated that the device was within normal range of operation.
 
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Brand Name
ANTHEM RF CRT-P
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key12368109
MDR Text Key268156454
Report Number2017865-2021-28989
Device Sequence Number1
Product Code NKE
UDI-Device Identifier05414734503785
UDI-Public05414734503785
Combination Product (y/n)N
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2013
Device Model NumberPM3210
Device Catalogue NumberPM3210
Device Lot Number3653154
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2021
Was the Report Sent to FDA? No
Date Manufacturer Received09/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TENDRIL STS; TENDRIL STS; TENDRIL STS; TENDRIL STS
Patient Outcome(s) Death;
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