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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 Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. Further information was requested but not received.
 
Event Description
It was reported that a possible explant and possible reuse of a pacemaker occurred. No intervention was performed. The patient's condition was unknown.
 
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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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
MDR Report Key9434673
MDR Text Key169792629
Report Number2017865-2019-17561
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2014
Device Model NumberPM3210
Device Lot Number3871139
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/07/2019 Patient Sequence Number: 1
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