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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ANTHEM RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ANTHEM RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3212
Device Problem Under-Sensing (1661)
Patient Problem Ventricular Tachycardia (2132)
Event Date 11/18/2019
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 2938836-2019-17386; 2938836-2019-17388.It was reported that following the patient¿s death, the device was interrogated and revealed episodes of inappropriate auto-mode switch (ams) due to atrial lead noise.An electrogram (egm) revealed sensing of ventricular tachycardia (vt) and recorded by the device as high ventricular rate (hvr).Some undersensing was observed on the pacemaker.Loss of capture was observed on the atrial and ventricular leads.The cause of the patient¿s death was vt and there was not fault of the leads nor pacemaker.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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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-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key9485388
MDR Text Key173773644
Report Number2938836-2019-17385
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2014
Device Model NumberPM3212
Device Lot Number4031998
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Was the Report Sent to FDA? No
Date Manufacturer Received06/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TENDRIL STS LEAD; TENDRIL STS LEAD
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