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) ACCENT DR RF PACEMAKER; 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) ACCENT DR RF PACEMAKER; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2210
Device Problem Difficult to Interrogate (1331)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/07/2017
Event Type  malfunction  
Event Description
It was reported that the device could not be interrogated.Two programmers were used and failed to interrogate the device.A firmware download was completed successfully and the device was able to be interrogated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACCENT DR RF PACEMAKER
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 Key6644619
MDR Text Key77665460
Report Number2017865-2017-03360
Device Sequence Number1
Product Code LWP
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,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2012
Device Model NumberPM2210
Device Lot Number3431316
Other Device ID Number05414734503617
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age66 YR
-
-