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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE RF IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE RF IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3222
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hypersensitivity/Allergic reaction (1907)
Event Date 06/05/2017
Event Type  Injury  
Event Description
It was reported that the patient presented in clinic with hematoma. The hematoma was evacuated. A few days later the patient observed discharge from the pocket area and a superphysical opening. The patient was brought into clinic for follow-up on (b)(6)2017. Drainage could not be confirmed however, a rash was noticed due to the antibiotic. The physician changed the antibiotic. The patient presented in clinic for follow-up on (b)(6)2017. During this follow-up, discharge was confirmed. Six days, a small hematoma was observed but was stable. The system was explanted on (b)(6)2017. Cultures taken during the procedure were negative for infection. The patient was healing fine.
 
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Brand NameALLURE RF
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6801282
MDR Text Key82935482
Report Number2017865-2017-08133
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Model NumberPM3222
Device Lot NumberA000038071
Other Device ID Number05414734507905
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2017
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: 08/17/2017 Patient Sequence Number: 1
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