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., CRMD IDENTITY ADX SR; 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., CRMD IDENTITY ADX SR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5180
Device Problems Difficult to Interrogate (1331); Premature End-of-Life Indicator (1480)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2014
Event Type  Injury  
Event Description
It was reported that during routine follow-up, the pulse generator could not be interrogated due to premature battery depletion.The device was explanted and replaced.
 
Manufacturer Narrative
Final analysis found that a capacitor anomaly resulted in the reported premature battery depletion.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IDENTITY ADX SR
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
cary lawler
15900 valley view court
sylmar, CA 91342
8184932621
MDR Report Key3920410
MDR Text Key4521420
Report Number2017865-2014-14006
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2012
Device Model Number5180
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/19/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-