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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Device Problem Therapy Delivered to Incorrect Body Area (1508)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Details are listed in the attached article, titled ¿improvement of lv reverse remodeling using dynamic programming of fusion-optimized atrioventricular intervals in cardiac resynchronization therapy. Front. Cardiovasc. Med. 8:700424. Doi: 10. 3389/fcvm. 2021. 700424" further information was requested but not received.
 
Event Description
It was reported through a research article that either a quadra allure pacemaker (pm) pm3140 or pm3242 may have caused phrenic nerve stimulation on a patient. Reprogramming was performed. No information was given regarding the involving product, healthcare provider and patient.
 
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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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key12636159
MDR Text Key278995596
Report Number2017865-2021-33059
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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