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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ALLURE RF IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC. ALLURE RF IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3222
Device Problems Signal Artifact/Noise (1036); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2017
Event Type  malfunction  
Manufacturer Narrative
Analysis of the atrial, right ventricular, and left ventricular connectors on the device revealed no anomalies. Electrical testing showed no indication of conductor fractures or internal shorts. The results of the investigation concluded the analysis of the device was normal with no anomalies found. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
During implantation procedure, noise was noted when the lead was connected to the header of the device, all electrical measurements were good connected to patient system analyzer (psa). Therefore, the device was exchanged and the patient was in stable condition.
 
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Brand NameALLURE RF
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6686333
MDR Text Key113806321
Report Number2017865-2017-05825
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Model NumberPM3222
Device Lot NumberA000035727
Other Device ID Number05414734507905
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2017
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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