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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
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ANTHEM RF CRT-P; IMPLANTABLE PACEMAKER Back to Search Results
Model Number PM3210
Medical Device Problem Codes Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/07/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported that an asymptomatic patient presented to a follow-up in-clinic with noise over-sensing causing inappropriate automatic mode switch episodes from their pacemaker.Noise was able to be reproduced during isometric exercises.Pacemaker mediated tachycardia was also noted.No intervention was performed and patient was stable after the event.
 
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Brand Name
ANTHEM RF CRT-P
Common Device Name
IMPLANTABLE PACEMAKER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key10715036
Report Number2017865-2020-15930
Device Sequence Number3899229
Product Code NKE
UDI-Device Identifier05414734503785
UDI-Public05414734503785
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P030035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/31/2014
Device Model NumberPM3210
Device Catalogue NumberPM3210
Device Lot Number3814469
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/07/2020
Initial Report FDA Received Date10/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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