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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 PM3212
Device Problem Failure to Interrogate (1332)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2020
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that the patient presented in the hospital to undergo cardiac re-synchronization therapy (crt) system implant surgery.During the operation, it was observed that the pacemaker, and telemeter could not be connected by inductive, or radiofrequency telemetry.The pacemaker was not used, and was replaced.The patient was stable throughout.
 
Manufacturer Narrative
The reported event of failure to interrogate was not confirmed by analysis.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-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key10823375
MDR Text Key215923520
Report Number2017865-2020-16245
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 12/16/2020
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
Device Operator Health Professional
Device Expiration Date05/31/2021
Device Model NumberPM3212
Device Lot NumberS000074104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/23/2020
Initial Date FDA Received11/11/2020
Supplement Dates Manufacturer Received12/09/2020
Supplement Dates FDA Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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