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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 PM3210
Device Problems Incorrect Measurement (1383); Low impedance (2285)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the dialysis patient presented in hospital, upon interrogation a polarity switch occurred due to low impedance, the device also exhibited inadequate measurements. The device was explanted and replaced successfully. No reported status for patient.
 
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Brand NameANTHEM RF CRT-P
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
jaime chavez
15900 valley view court
sylmar, CA 91342
8184934022
MDR Report Key5471180
MDR Text Key39386463
Report Number2017865-2016-00865
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2011
Device Model NumberPM3210
Device Lot Number2858495
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2009
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: 03/01/2016 Patient Sequence Number: 1
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