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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 PM3210
Device Problems Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2019
Event Type  Injury  
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. Further information was requested but not received.
 
Event Description
It was reported that when the patient presented in clinic for a routine follow up, false elective replacement indicator (eri) and end of service (eos) alerts were observed. Radio frequency (rf) lockout was also noted on the device. The patient underwent atrioventricular (av) node ablation a month before the event. It was confirmed that the false alert was due to cautery interference. Suggested programming change was declined since it would cause the device to pace with backup vvi settings. The patient is dependent. The patient will continue to be monitored. No patient symptoms were reported.
 
Manufacturer Narrative
Additional information: the results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
New information received notes that the device was explanted and replaced on (b)(6) 2020. The patient was stable.
 
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Brand NameANTHEM RF CRT-P
Type of DeviceIMPLANTABLE 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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key9219941
MDR Text Key163195936
Report Number2938836-2019-15445
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2015
Device Model NumberPM3210
Device Catalogue NumberPM3210
Device Lot Number4292226
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/22/2019 Patient Sequence Number: 1
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