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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ACCENT DR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ACCENT DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2112
Device Problem Programming Issue (3014)
Patient Problems Syncope (1610); Bradycardia (1751)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had experience syncope in the prior week, he was admitted to the hospital and experienced another episode.During interrogation the electrocardiogram exhibited bradycardia.The device was reprogrammed and the patient was stable and discharged.No issue after reprogramming.
 
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Brand Name
ACCENT DR
Type of Device
IMPLANTABLE 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
jaime chavez
15900 valley view court
sylmar, CA 91342
8184934022
MDR Report Key5901396
MDR Text Key52939729
Report Number2017865-2016-05529
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2011
Device Model NumberPM2112
Device Lot Number3147747
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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