Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ANTHEM RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3212
Device Problem No Device Output (1435)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient presented in clinic for normal device change out procedure.Burn marks were noted on the pulse generator and loss of output was noted.The device was explanted and replaced.The patient experienced no adverse consequences and would continue to be monitored.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANTHEM RF CRT-P
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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6214379
MDR Text Key63781447
Report Number2017865-2016-08090
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2013
Device Model NumberPM3212
Device Lot Number3715641
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-